Perceptive Regulatory Consulting

Robert Gadimian earned his Master in Pharmacy degree from the distinguished Uppsala Universit in Sweden. He is a regulatory sciences executive with demonstrated expertise in leading multidisciplinary, cross-functional teams to obtain regulatory approvals to market novel and innovative pharmaceutical drug products.

Robert is a Regulatory Affairs professional with 20 years of direct and first-hand global Regulatory experience in both Big-Pharma and small biotech companies located in The USA and EU. The experience encompasses the full spectrum of drug-development expertise (pre-IND to marketed products) and has been involved in the development of multiple pharmaceutical products. I have managed the global regulatory challenges associated in drug development and has gained experience in handling a wide range of drug development issues.

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You need to be sure that a qualified, Regulatory professional is on your team during the development of new pharmaceutical products and preparing for NDA/MAA submission. The right scientific advice from your Reg CMC professional could be invaluable. Perceptive Regulatory Consulting has proven Regulatory CMC expertise and experience. Perceptive Regulatory Consulting provides all level Regulatory CMC consulting services for Pharma and Biopharma companies regarding drugs under development to post-approval life cycle management issues. With more than 20 years of experience in the global pharmaceutical industry, Perceptive Regulatory Consulting will provide you with an advantage.

Providing strategic advice on Regulatory CMC issues and Pharmaceutical Development Plan. Oversight of Contract Manufacturing Organization (CMOs). Preparing the CMC section of the IND and CTAs for US and global clinical studies. Clinical material Labeling. Development of Regulatory CMC plan and its implementation. Review and assessment of Module 3 and Module 2 content and assist with deciding the correct level of details for these Modules. Post-approval life cycle management and compliance. Interpretation and Application of CMC Regulatory Regulations and Guidances for Investigational New Drugs (IND), New Drug Applications (NDA), and Drug Master Files (DMF). Gap Analysis. Due Diligence. Mitigation Strategies for CMC Regulatory Conformance and Compliance. Preparation and Participation in FDA CMC meeting or European Medicines Agency (EMA) Scientific Advice Meetings.