RGA 6207 Week 5 Module Significance from an Objective Perspective Discussion

FIND A SOLUTION AT Academic Writers Bay

Darin S. Oppenheimer, DRSc, FRAPS, RAC Week 5 Fall 2020 Today’s Objectives 2 Module 3 Module 3 Quality 3.2 Body of data 3.2.S Drug substance [name, manufacturer] 3.2.S.1 General information 3.2.S.1.1 Nomenclature 3.2.S.1.2 Structure 3.2.S.1.3 General properties 3.2.S.2 Manufacture 3.2.S.2.1 Manufacturer(s) 3.2.S.2.2 Description of Manufacturing Process and Process Controls 3.2.S.2.3 Control of Materials 3.2.S.2.4 Controls of Critical Steps and Intermediates 3.2.S.2.5 Process Validation and/or Evaluation 3.2.S.2.6 Manufacturing Process Development 3.2.S.3 Characterization 3.2.S.3.1 Elucidation of Structure and other Characteristics 3.2.S.3.2 Impurities 3.2.S.4 Control of drug substance 3.2.S.4.1 Specification 3.2.S.4.2 Analytical Procedures 3.2.S.4.3 Validation of Analytical Procedures 3.2.S.4.4 Batch Analyses 3.2.S.4.5 Justification of Specification 3.2.S.5 Reference standards or materials 3.2.S.6 Container closure systems 3.2.S.7 Stability 3.2.S.7.1 Stability Summary and Conclusions 3.2.S.7.2 Post Approval Stability Protocol and Stability Commitment 3.2.S.7.3 Stability Data 3.2.P Drug product [name, dosage form, manufacturer] 3 Module 3 3.2.P.1 Description and composition of the drug product 3.2.P.2 Pharmaceutical development 3.2.P.3 Manufacture 3.2.P.3.1 Manufacturer(s) 3.2.P.3.2 Batch Formula 3.2.P.3.3 Description of Manufacturing Process and Process Controls 3.2.P.3.4 Controls of Critical Steps and Intermediates 3.2.P.3.5 Process Validation and/or Evaluation 3.2.P.4 Control of excipients [name] 3.2.P.4.1 Specification(s) 3.2.P.4.2 Analytical Procedures 3.2.P.4.3 Validation of Analytical Procedures 3.2.P.4.4 Justification of Specifications 3.2.P.4.5 Excipients of Human or Animal Origin 3.2.P.4.6 Novel Excipients 3.2.P.5 Control of drug product 3.2.P.5.1 Specification(s) 3.2.P.5.2 Analytical Procedures 3.2.P.5.3 Validation of Analytical Procedures 3.2.P.5.4 Batch Analyses 3.2.P.5.5 Characterization of Impurities 3.2.P.5.6 Justification of Specification(s) 3.2.P.6 Reference standards or materials 3.2.P.7 Container closure system 3.2.P.8 Stability 3.2.P.8.1 Stability Summary and Conclusion 3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment 3.2.P.8.3 Stability Data 3.2.A Appendices 3.2.A.1 Facilities and Equipment [name, manufacturer] 3.2.A.2 Adventitious agents safety evaluation [name, dosage form, manufacturer] 3.2.A.3 Novel excipients 3.2.R Regional information 3.3 Literature references 4 Module 3 Quality • 3.1 MODULE 3 TABLE OF CONTENTS A Table of Contents for the filed application should be provided. • 3.2 BODY OF DATA • 3.2.S DRUG SUBSTANCE [NAME, MANUFACTURER]4 • 3.2.S.1 General Information [name, manufacturer] • 3.2.S.1.1 Nomenclature[name, manufacturer] Information on the nomenclature of the drug substance should be provided. For exle: • Recommended International Nonproprietary Name (INN) • Compendial name if relevant • Chemical name(s) • Company or laboratory code • Other nonproprietary name(s) (e.g., national name, United States Adopted Name (USAN), Japanese Accepted Name (JAN); British Approved Name (BAN)) • Chemical Abstracts Service (CAS) registry number 5 Module 3 Quality • 3.2.S.1.2 Structure[name, manufacturer] • 3.2.S.1.3 General Properties[name, manufacturer] A list should be provided of physicochemical and other relevant properties of the drug substance, including biological activity for Biotech. • 3.2.S.2 Manufacture [name, manufacturer] • 3.2.S.2.1 Manufacturers[name, manufacturer] The name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing should be provided. • 3.2.S.2.2 Description of Manufacturing Process and Process Controls [name, manufacturer] The description of the drug substance manufacturing process represents the applicant’s commitment for the manufacture of the drug substance. Information should be provided to adequately describe the manufacturing process and process controls. 6 Module 3 Quality • 3.2.S.2.3 Control of Materials • Materials used in the manufacture of the drug substance (e.g., raw materials, starting materials, solvents, reagents, catalysts) should be listed, identifying where each material is used in the process. • Information on the quality and control of these materials should be provided. • Information demonstrating that materials (including biologically sourced materials (e.g., media components, monoclonal antibodies, enzymes)) meet standards appropriate for their intended use (including the clearance or control of adventitious agents) should be provided, as appropriate. • For biologically sourced materials, this can include information on the source, manufacture, and characterization. (Provide details in Appendix 3.2.A.2 for both NCE and Biotech.) 7 Module 3 Quality • 3.2.S.2.4 Controls of Critical Steps and Intermediates [name, manufacturer] Critical Steps: Tests and acceptance criteria (with justification including experimental data) performed at critical steps identified in 3.2.S.2.2 of the manufacturing process to ensure that the process is controlled should be provided. Intermediates: Information on the quality and control of intermediates isolated during the process should be provided. • 3.2.S.2.5 Process Validation and/or Evaluation[name, manufacturer] Process validation and/or evaluation studies for aseptic processing and sterilization should be included. • 3.2.S.2.6 Manufacturing Process Development [name, manufacturer] 8 Module 3 Quality • 3.2.S.3 Characterization [name, manufacturer] • 3.2.S.3.1 Elucidation of Structure and other Characteristics [name, manufacturer] • 3.2.S.3.2 Impurities [name, manufacturer] Information on impurities should be provided. Reference ICH guidances Q3A, Q3C, Q5C, Q6A, and Q6B. • 3.2.S.4 Control of Drug Substance [name, manufacturer] • 3.2.S.4.1 Specification [name, manufacturer] The specification for the drug substance should be provided. • 3.2.S.4.2 Analytical Procedures [name, manufacturer] The analytical procedures used for testing the drug substance should be provided. Reference ICH guidances Q2A and Q6B. 9 Module 3 Quality 3.2.S.4.3 Validation of Analytical Procedures [name, manufacturer] Analytical validation information, including experimental data for the analytical procedures used for testing the drug substance, should be provided. Reference ICH guidances Q2A, Q2B, and Q6B. 3.2.S.4.4 Batch Analyses [name, manufacturer] Description of batches and results of batch analyses should be provided. Reference ICH guidances Q3A, Q3C, Q6A, and Q6B. 3.2.S.4.5 Justification of Specification [name, manufacturer] Justification for the drug substance specification should be provided. Reference ICH guidances Q3A, Q3C, Q6A, and Q6B. 10 Module 3 Quality 3.2.S.4.3 Validation of Analytical Procedures [name, manufacturer] Analytical validation information, including experimental data for the analytical procedures used for testing the drug substance, should be provided. Reference ICH guidances Q2A, Q2B, and Q6B. 3.2.S.4.4 Batch Analyses [name, manufacturer] Description of batches and results of batch analyses should be provided. Reference ICH guidances Q3A, Q3C, Q6A, and Q6B. 3.2.S.4.5 Justification of Specification [name, manufacturer] Justification for the drug substance specification should be provided. Reference ICH guidances Q3A, Q3C, Q6A, and Q6B. 11 Module 3 Quality 3.2.S.5 Reference Standards or Materials [name, manufacturer] Information on the reference standards or reference materials used for testing of the drug substance should be provided. 3.2.S.6 Container Closure System [name, manufacturer] A description of the container closure systems should be provided, including the identity of materials of construction of each primary packaging component, and their specifications. The specifications should include description and identification (and critical dimensions with drawings, where appropriate). Noncompendial methods (with validation) should be included, where appropriate. For nonfunctional secondary packaging components (e.g., those that do not provide additional protection), only a brief description should be provided. For functional secondary packaging components, additional information should be provided. The suitability should be discussed with respect to, for exle, choice of materials, protection from moisture and light, compatibility of the materials of construction with the drug substance, including sorption to container and leaching, and/or safety of materials of 12 construction. Module 3 Quality 3.2.S.7 Stability [name, manufacturer] 3.2.S.7.1 Stability Summary and Conclusions [name, manufacturer] The types of studies conducted, protocols used, and the results of the studies should be summarized. The summary should include results, for exle, from forced degradation studies and stress conditions, as well as conclusions regarding storage conditions and retest date or shelf life, as appropriate. 3.2.S.7.2 Postapproval Stability Protocol and Stability Commitment [name, manufacturer] approval stability protocol and stability commitment should be provided. 3.2.S.7.3 Stability Data [name, manufacturer] Results of the stability studies (e.g., forced degradation studies and stress conditions) should be presented in an appropriate format such as tabular, graphic, or narrative. Information on the analytical procedures used to generate the data and validation of these procedures should be included. 13 Module 3 Quality 3.2.P DRUG PRODUCT [NAME, DOSAGE FORM] 3.2.P.1 Description and Composition of the Drug Product [name dosage form] A description of the drug product and its composition should be provided. The information provided should include, for exle: Description of the dosage form Composition (i.e., list of all components of the dosage form and their amount on a per unit basis (including overages, if any)) the function of the components, and a reference to their quality standards (e.g., compendial monographs or manufacturer’s specifications) Description of accompanying reconstitution diluents Type of container and closure used for the dosage form and accompanying reconstitution diluent, if applicable Reference ICH guidances Q6A and Q6B. 14 Module 3 Quality 3.2.P.2 Pharmaceutical Development [name, dosage form] The Pharmaceutical Development section should contain information on the development studies conducted to establish that the dosage form, the formulation, manufacturing process, container closure system, microbiological attributes, and usage instructions are appropriate for the purpose specified in the application. The studies described in this section should be distinguished from routine control tests conducted according to specifications. Additionally, this section should identify and describe the formulation and process attributes (critical parameters) that can influence batch reproducibility, product performance, and drug product quality. Supportive data and results from specific studies or published literature can be included within or attached to the Pharmaceutical Development section. Additional supportive data can be referenced to the relevant nonclinical or clinical sections of the application. Reference ICH guidances Q6A and Q6B 3.2.P.2.1 Components of the Drug Product [name, dosage form] 3.2.P.2.1.1 Drug Substance [name, dosage form] The compatibility of the drug substance with the excipients listed in 3.2.P.1 should be discussed. Additionally, key physicochemical characteristics (e.g., water content, solubility, particle size distribution, polymorphic or solid state form) of the drug substance that can influence the performance of the drug product should be discussed. 15 Module 3 Quality 3.2.P.2.1.2 Excipients[name, dosage form] The choice of excipients listed in 3.2.P.1, their concentration, and the characteristics that can influence the drug product performance should be discussed relative to their respective functions. 3.2.P.2.2 Drug Product [name, dosage form] 3.2.P.2.2.1 Formulation Development [name, dosage form] A brief summary describing the development of the drug product should be provided, taking into consideration the proposed route of administration and usage. The differences between clinical formulations and the formulation (i.e., composition) described in 3.2.P.1 should be discussed. Results from comparative in vitro studies (e.g., dissolution) or comparative in vivo studies (e.g., bioequivalence) should be discussed when appropriate. 16 Module 3 Quality 3.2.P.2.2.2 Overages [name, dosage form] Any overages in the formulations described in P1 should be justified. 3.2.P.2.2.3 Physicochemical and Biological Properties [name, dosage form] Parameters relevant to the performance of the drug product, such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, aggregation, polymorphism, rheological properties, biological activity or potency, and/or immunological activity, should be addressed. 3.2.P.2.3 Manufacturing Process Development [name, dosage form] The selection and optimization of the manufacturing process described in 3.2.P.3.3, in particular its critical aspects, should be explained. Where relevant, the method of sterilization should be explained and justified. Differences between the manufacturing processes used to produce pivotal clinical batches and the process described in 3.2.P.3.3 that can influence the performance of the product should be discussed. 17 Module 3 Quality 3.2.P.2.4 Container Closure System [name, dosage form] The suitability of the container closure system (described in 3.2.P.7) for the storage, transportation (shipping), and use of the drug product should be discussed. This discussion should consider, for exle, choice of materials, protection from moisture and light, compatibility of the materials of construction with the dosage form (including sorption to container and leaching), safety of materials of construction, and performance (such as reproducibility of the dose delivery from the device when presented as part of the drug product). 3.2.P.2.5 Microbiological Attributes [name, dosage form] Where appropriate, the microbiological attributes of the dosage form should be discussed, including, for exle, the rationale for not performing microbial limits testing for nonsterile products and the selection and effectiveness of preservative systems in products containing antimicrobial preservatives. For sterile products, the integrity of the container closure system to prevent microbial contamination should be addressed. 18 Module 3 Quality 3.2.P.2.6 Compatibility[name, dosage form] The compatibility of the drug product with reconstitution diluents or dosage devices (e.g., precipitation of drug substance in solution, sorption on injection vessels, stability) should be addressed to provide appropriate and supportive information for the labeling. 3.2.P.3 Manufacture [name, dosage form] 3.2.P.3.1 Manufacturers [name, dosage form] The name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing should be provided. 3.2.P.3.2 Batch Formula [name, dosage form] A batch formula should be provided that includes a list of all components of the dosage form to be used in the manufacturing process, their amounts on a per batch basis, including 19 overages, and a reference to their quality standards. Module 3 Quality 3.2.P.3.3 Description of Manufacturing Process and Process Controls [name, dosage form] A flow diagram should be presented giving the steps of the process and showing where materials enter the process. The critical steps and points at which process controls, intermediate tests, or final product controls are conducted should be identified. A narrative description of the manufacturing process, including packaging, that represents the sequence of steps undertaken and the scale of production should also be provided. Novel processes or technologies and packaging operations that directly affect product quality should be described with a greater level of detail. Equipment should, at least, be identified by type (e.g., tumble blender, in-line homogenizer) and working capacity, where relevant. Steps in the process should have the appropriate process parameters identified, such as time, temperature, or pH. Associated numeric values can be presented as an expected range. Numeric ranges for critical steps should be justified in 3.2.P.3.4. In certain cases, environmental conditions (e.g., low humidity for an effervescent product) should be stated. Proposals for the reprocessing of materials should be justified. Any data to support this justification should be either referenced or filed in this section (3.2.P.3.3). 20 Module 3 Quality 3.2.P.3.4 Controls of Critical Steps and Intermediates [name, dosage form] Critical Steps: Tests and acceptance criteria (with justification, including experimental data) performed at the critical steps identified in 3.2.P.3.3 of the manufacturing process should be provided to ensure that the process is controlled. Intermediates: Information on the quality and control of intermediates isolated during the process should be provided. 3.2.P.3.5 Process Validation and/or Evaluation [name, dosage form] Description, documentation, and results of the validation and/or evaluation studies should be provided for critical steps or critical assays used in the manufacturing process (e.g., validation of the sterilization process or aseptic processing or filling). Viral safety evaluation should be provided in Appendix 3.2.A.2, if necessary. 21 Module 3 Quality 3.2.P.4 Control of Excipients [name, dosage form] 3.2.P.4.1 Specifications [name, dosage form] The specifications for excipients should be provided. Reference ICH guidances Q6A and Q6B. 3.2.P.4.2 Analytical Procedures [name, dosage form] The analytical procedures used for testing the excipients should be provided, where appropriate. Reference ICH guidances Q2A and Q6B. 3.2.P.4.3 Validation of Analytical Procedures [name, dosage form] Analytical validation information, including experimental data, for the analytical procedures used for testing the excipients should be provided, where appropriate. Reference ICH guidances Q2A, Q2B, and Q6B. 3.2.P.4.4 Justification of Specifications [name, dosage form] Justification for the proposed excipient specifications should be provided, where appropriate. Reference ICH guidances Q3C and Q6B. 22 Module 3 Quality 3.2.P.4.5 Excipients of Human or Animal Origin [name, dosage form] For excipients of human or animal origin, information should be provided regarding adventitious agents (e.g., sources, specifications, description of the testing performed, viral safety data). (Provide details in Appendix 3.2.A.2). Reference ICH guidances Q5A, Q5D, and Q6B. 3.2.P.4.6 Novel Excipients [name, dosage form] For excipients used for the first time in a drug product or by a new route of administration, full details of manufacture, characterization, and controls, with cross-references to supporting safety data (nonclinical and/or clinical), should be provided according to the drug substance format. 23 Module 3 Quality 3.2.P. 5 Control of Drug Product [name, dosage form] 3.2.P.5.1 Specifications [name, dosage form] The specifications for the drug product should be provided. Reference ICH guidances Q3B, Q6A, and Q6B. 3.2.P.5.2 Analytical Procedures [name, dosage form] The analytical procedures used for testing the drug product should be provided. Reference ICH guidances Q2A and Q6B. 3.2.P.5.3 Validation of Analytical Procedures [name, dosage form] Analytical validation information, including experimental data, for the analytical procedures used for testing the drug product should be provided. Reference ICH guidances Q2A, Q2B, and Q6B. 3.2.P.5.4 Batch Analyses [name, dosage form] A description of batches and results of batch analyses should be provided. Reference ICH guidances Q3B, Q3C, Q6A, and Q6B. 24 Module 3 Quality 3.2.P.5.5 Characterization of Impurities [name, dosage form] Information on the characterization of impurities should be provided if not previously provided in 3.2.S.3.2, Impurities. Reference ICH guidances Q3B, Q5C, Q6A, and Q6B. 3.2.P.5.6 Justification of Specifications [name, dosage form] Justification for the proposed drug product specifications should be provided. Reference ICH guidances Q3B, Q6A, and Q6B. 3.2.P.6 Reference Standards or Materials [name, dosage form] Information on the reference standards or reference materials used for testing of the drug product should be provided if not previously provided in 3.2.S.5, Reference Standards or Materials. Reference ICH guidances Q6A and Q6B. 25 Module 3 Quality 3.2.P.7 Container Closure System [name, dosage form] A description of the container closure systems should be provided, including the identity of materials of construction of each primary packaging component and its specification. The specifications should include description and identification (and critical dimensions, with drawings where appropriate). Noncompendial methods (with validation) should be included where appropriate. For nonfunctional secondary packaging components (e.g., those that neither provide additional protection nor serve to deliver the product), only a brief description should be provided. For functional secondary packaging components, additional information should be provided. Suitability information should be located in 3.2.P.2. 26 Module 3 Quality 3.2.P.8 Stability [name, dosage form] 3.2.P.8.1 Stability Summary and Conclusion [name, dosage form] The types of studies conducted, protocols used, and the results of the studies should be summarized. The summary should include, for exle, conclusions regarding storage conditions and shelf life, and, if applicable, in-use storage conditions and shelf life. Reference ICH guidances Q1A, Q1B, Q3B, Q5C, and Q6A. 3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment [name, dosage form] approval stability protocol and stability commitment should be provided. Reference ICH guidances Q1A and Q5C. 27 Module 3 Quality 3.2.P.8.3 Stability Data [name, dosage form] Results of the stability studies should be presented in an appropriate format (e.g., tabular, graphic, narrative). Information on the analytical procedures used to generate the data and validation of these procedures should be included. Information on characterization of impurities is located in 3.2.P.5.5. Reference ICH guidances Q1A , Q1B, Q2A, Q2B, and Q5C. 3.2.A APPENDICES 3.2.A.1 Facilities and Equipment 28 Module 3 Quality 3.2.A.2 Adventitious Agents Safety Evaluation Information assessing the risk of potential contamination with adventitious agents should be provided in this section. For nonviral adventitious agents: Detailed information should be provided on the avoidance and control of nonviral adventitious agents (e.g., transmissible spongiform encephalopathy agents, bacteria, mycoplasma, fungi). This information can include, for exle, certification and/or testing of raw materials and excipients and control of the production process, as appropriate for the material, process and agent. Reference ICH guidances Q5A, Q5D, and Q6B. 29 Module 3 Quality For viral adventitious agents: Detailed information from viral safety evaluation studies should be provided in this section. Viral evaluation studies should demonstrate that the materials used in production are considered safe, and that the approaches used to test, evaluate, and eliminate the potential risks during manufacturing are suitable. The applicant should refer to Q5A, Q5D, and Q6B for further guidance. Information essential to evaluate the virological safety of materials of animal or human origin (e.g. biological fluids, tissue, organ, cell lines) should be provided. (See related information in 3.2.S.2.3, and 3.2.P.4.5). For cell lines, information on the selection, testing, and safety assessment for potential viral contamination of the cells and viral qualification of cell banks should also be provided. (See related information in 3.2.S.2.3). 30 Module 3 Quality For viral adventitious agents: The selection of virological tests that are conducted during manufacturing (e.g., cell substrate, unprocessed bulk, or postviral clearance testing) should be justified. The type of test, sensitivity and specificity of the test, if applicable, and frequency of testing should be included. Test results to confirm, at an appropriate stage of manufacture, that the product is free from viral contamination should be provided. (See related information in 3.2.S.2.4 and 3.2.P.3.4). In accordance with Q5A and Q6B, results for viral testing of unprocessed bulk should be included. In accordance with Q5A, the rationale and action plan for assessing viral clearance and the results and evaluation of the viral clearance studies should be provided. Data can include those that demonstrate the validity of the scaled-down model compared to the commercial scale process, the adequacy of viral inactivation or removal procedures for manufacturing equipment and materials, and manufacturing steps that are capable of removing or inactivating viruses. (See related information in 3.2.S.2.5 and 3.2.P.3.5). Reference ICH guidances Q5A, Q5D, and Q6B. 31 Module 3 Quality 3.2.A.3 Novel Excipients 3.2.R REGIONAL INFORMATION Any additional drug substance and/or drug product information specific to each region should be provided in section R of the application. Applicants should consult the appropriate regional guidance and/or regulatory authorities for additional guidance. Some exles are as follows: Executed Batch Records (USA only) Method Validation Package (USA only) Comparability Protocols (USA only) Process Validation Scheme for the Drug Product (EU only ) Where validation is still to be completed, a summary of the studies intended to be conducted should be provided. Medical Device (EU only) 3.3 LITERATURE REFERENCES Key literature referenced should be provided, if applicable. 32 Thank you! Questions? 33

• WE OFFER THE BEST CUSTOM PAPER WRITING SERVICES. WE HAVE DONE THIS QUESTION BEFORE, WE CAN ALSO DO IT FOR YOU.
• Assignment status: Already Solved By Our Experts
• (USA, AUS, UK ; CA PhD. Writers)
• CLICK HERE TO GET A PROFESSIONAL WRITER TO WORK ON THIS PAPER AND OTHER SIMILAR PAPERS, GET A NON PLAGIARIZED PAPER FROM OUR EXPERTS

QUALITY: ORIGINAL PAPER – NO PLAGIARISM - CUSTOM PAPER

Why Choose Us?

How It Works

• Click on the “Place Your Order” tab at the top menu or “Order Now” icon at the bottom and a new page will appear with an order form to be filled.
• Fill in your paper’s requirements in the "PAPER DETAILS" section.
• Fill in your paper’s academic level, deadline, and the required number of pages from the drop-down menus.
• Click “CREATE ACCOUNT ; SIGN IN” to enter your registration details and get an account with us for record-keeping and then, click on “PROCEED TO CHECKOUT” at the bottom of the page.
• From there, the payment sections will show, follow the guided payment process and your order will be available for our writing team to work on it.

About AcademicWritersBay.com

AcademicWritersBay.comnbsp;is an easy-to-use and reliable service that is ready to assist you with your papers 24/7/ 365days a year. 99% of our customers are happy with their papers. Our team is efficient and will always tackle your essay needs comprehensively assuring you of excellent results. Feel free to ask them anything concerning your essay demands or Order.

AcademicWritersBay.com is a private company that offers academic support and assistance to students at all levels. Our mission is to provide proficient andnbsp;high quality academic servicesnbsp;to our highly esteemed clients. AcademicWritersBay.com is equipped with competent andnbsp;proficient writersnbsp;to tackle all types of your academic needs, and provide you with excellent results. Most of our writers are holders ofnbsp;master's degreesnbsp;ornbsp;PhDs, which is an surety of excellent results to our clients. We provide assistance to students all over the world.
We provide high quality term papers, research papers, essays, proposals, theses and many others. Atnbsp;AcademicWritersBay.com, you can be sure ofnbsp;excellent gradesnbsp;in your assignments and final exams.