Pharmaceutical/Cosmetic Science & Technology
Claims Substantiation
Validation and Compliance
Legal and Ethical Issues

Active Pharmaceutical Ingredients: Developments, Manufacturing and Regulations, 2nd edition (Nusim) 299.95
Analytical Chemistry in a GMP Environment (Miller) 174.00
Analytical Method Validation and Instrument Performance Verification (Chan/Lee/Lam/Zhang) 110.50
Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries (Haider) 138.95
Combination Products: Regulatory Challenges and Successful Product Development (Gopalaswamy) 145.95
Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry (Lopez) 228.95
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics (Medina) 298.95
Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies (Wingate)548.95
Control of Particulate Matter Contamination in Healthcare Manufacturing (Barber) 318.95
Development and Evaluation of Drugs from Laboratory through Licensure to Market
2nd edition (Lee)
Dietary Supplement Good Manufacturing Practices: Preparing for Compliance (Mead) 198.95
Drugs from Discovery to Approval, 2nd edition (Ng) 88.95
Establishing a CGMP Laoratory Audit System: A Practical Guide (Bliesner) 104.00
Facility Validation: Theory, Practice, and Tools (Wrigley) 148.95
FDA Administrative Enforcement Manual (Parker) 198.95
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (Pisano and Mantus) 198.95
FDA-Speak: A Glossary and Agency Guide (Snyder) 228.95
Generic Drug Product Development: International Regulatory Requirements for Bioequivalence (Kanfer) 249.00
Genetic Testing: Care Consent and Liability (Sharpe) 100.95
Global Pharmaceutical Marketing: A Practical Guide to Codes and Compliance (Grice) 149.95
Global Regulatory Issues for the Cosmetics Industry (Betton) 136.00
GLP Essentials: A Concise Guide to Good Laboratory Practice 2nd edition (Anderson) 59.95
Good Laboratory Practice, 2nd edition (Seiler) 268.00
Good Laboratory Practice Regulations, 4th edition (Weinberg) 228.95
Good Pharmaceutical Manufacturing Practice: Rationale and Compliance (Sharp) 298.95
Guidebook for Drug Regulatory Submissions (Weinberg) 98.95
Handbook of Biogeneric Therapeutic Proteins: Regulatory Manufacturing Testing and Patent Issues (Niazi) 248.95
Handbook of Microbiological Quality Control Pharmaceuticals and Medical Devices (Baird) 178.95
Handbook of SOPs for Good Clinical Practice 2nd edition (Clive) 298.95
In Silico Technologies in Drug Target Identification and Validation (Leon) 148.95
International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries (Segalstad) 149.00
International Pharmaceutical Product Registration, 2nd edition (Cartwright) 549.00
Laboratory Auditing for Quality and Regulatory Compliance (Singer) 228.95
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices (Tobin) 90.00
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice (Ermer and Miller) 254.00
New Drug Approval Process, 5th edition (Guarino) 289.95
New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics (Sahajwalla) 228.95
Pharmaceutical and Medical Device Validation by Experimental Design (Torbeck) 228.95
Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance, 2nd edition (Wingate) 598.95
Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook (Cloud) 298.95
Pharmaceutical Manufacturing Handbook: Regulations and Quality (Gad) 194.00
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance (Haider) 238.00
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, 2nd edition (Hynes) 228.95
Pharmaceutical Process Validation (Nash and Wachter) 298.95
Pharmaceutical Quality Systems (Schmidt) 258.95
The Pharmaceutical Regulatory Process, 1st edition (Berry) Special Price 99.95
The Pharmaceutical Regulatory Process, 2nd edition (Berry) 248.95
Pharmaceutical Water: Systems Design, Operation, and Validation, 2nd edition (Collentro) 323.00
Pharmacovigilance, 2nd edition (Mann) 354.00
Principles and Practice of Pharmaceutical Medicine, 2nd edition (Edwards) 249.00
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices and Industrial Case Studies (Rathore) 244.95
Quality Assurance in Analytical Chemistry: Training and Teaching, 2nd edition (Wenclawiak, Koch, and Hadjicostas) 98.00
Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories (Haider) 139.95
Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives (Zhou) 124.00
Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 75.00
Software Development and Quality Assurance for the Healthcare Manufacturing Industries 3rd edition (Mallory) 298.95
Software Quality Assurance SOPs for Healthcare Manufacturers 2nd edition (Mallory) 248.95
Statistical Thinking for Non-Statisticians in Drug Regulation (Kay) 84.00
Strauss' Federal Drug Laws and Examination Review 5th edition 89.95
Testing Computers Systems for FDA/MCA Compliance (Stokes) 198.95
Validated Cleaning Technologies for Pharmaceutical Manufacturing (LeBlanc) 258.95
Validating Chromatographic Methods: A Practical Guide (Bliesner) 83.95
Validating Medical Packaging (Pilchik) 188.95
Validation and Qualification in Analytical Laboratories, 2nd edition (Huber) 249.95
Validation of Active Pharmaceutical Ingredients 2nd edition (Berry) 338.95
Validation of Cell-Based Assays in the GLP Setting: A Practical Guide (Prabhakar) 149.00
Validation of Pharmaceutical Processes, 3rd edition (Agalloco) 355.00
Validation Standard Operating Procedures Book + CD-ROM, 2nd edition (Haider) 298.95
Write It Down: Guidance for Preparing Effective and Compliant Documentation, 2nd edition (Gough) 248.95
Prices subject to change - Prices are in U.S. Dollars

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