The Pharmaceutical Regulatory Process

About

IRA R. BERRY is President and Founder of International Regulatory Business Consultants L.L.C. Freehold New Jersey USA. Ira Berry received his M.A. in Biology from Hofstra University Hempstead New York USA and his M.B.A. in Management from Adelphi University Garden City New York USA. He has created a consulting business with his extensive experience in the global areas of pharmaceutical manufacturing operations quality systems compliance regulatory affairs and business developmentfor APIs and dosage forms. He provides instructions and conducts plant audits for CGMP compliance quality systems evaluation SOPs preparing and filing Drug Master Files and dosage form product registrations and personnel training. His professional affiliations include his membership in the Generic Pharmaceutical Association and International Generic Pharmaceutical Association. Berry has worked extensively with Development and Task Force committees with the FDA and is a recognized health care manufacturing industry expert. He was Co-editor of Informa Healthcares first edition of The Pharmaceutical Regulatory Process as well as the titles Pharmaceutical Process Validation and Validation of Active Pharmaceutical Ingredients. Berry also contributed to several chapters in the Encyclopedia of Pharmaceutical Technology.ROBERT P. MARTIN is a consultant at RPMartin Consulting Lebanon Pennsylvania USA. Dr. Martin received both his M.S. and Ph.D degrees from the University of California Riverside California USA. Throughout his career he has held positions at many pharmaceutical companies including Forest Laboratories (as Associate Director of Quality Assurance) Duramed Pharmaceuticals (as Director of Quality Services) Merck & Co. (as Senior Scientist) and Johnson & Johnson (in several positions including Manager of Quality Services). In these positions he led efforts to improve performance in Research and Development by developing and implementing compliance and quality systems. At his consulting firm he currently provides an array of pharmaceutical consulting services including such as vendor risk analysis and management bioanalytical and analytical laboratory qualification/validation manufacturing qualification/validation auditing documentation CMC preparation DMF preparation and training.