Robert Kadimian earned his Master in Pharmacy degree from the distinguished Uppsala Universit in Sweden and earned Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).
Rafe Pharma by
Robert Kadimian
He earned his Master in Pharmacy degree from the distinguished Uppsala Universit in Sweden and earned Regulatory Affairs Certification... Read More...
Robert Gadimian

Rafe Pharma founded in 2016 by Robert Gadimian with the primary focus to provide strategic, senior level, executive CMC Regulatory Sciences consulting services to the pharmaceutical and biopharmaceutical industries.

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About Robert Kadimian

Robert Kadimian earned his Master in Pharmacy degree from the distinguished Uppsala Universit in Sweden and earned Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS). He is a Chemistry, Manufacturing, and Controls (CMC) regulatory sciences executive with demonstrated expertise in leading multidisciplinary, cross-functional teams to obtain regulatory approvals to market novel and innovative pharmaceutical drug substances and drug products and is experienced in the management and maintenance of Post-Approval... Read More...

Expert Consulting

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

Consulting services

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.

REGULATORY CMC CHALENGES

- Lack of global harmonization
- Increased compliance standards from health authorities
- Changes triggered by enhancement of science, medicine and technology
- Encourages risk-based approaches but yet conservative
- Encourages implementation of modern science and technology
- Heightened focus on geriatrics and pediatrics
- Increasing regulations
- Concerns about issues such as adulteration and counterfeits

You are in the good hands