Regulatory Affairs & Marketing Authorizations

Apothecaries has Managed 300+ Marketing Authorizations for Pharma MNCs.

We can hold Your Marketing Authorizations as Custodians, while your products' rights/IP remain with you. Whenever you are ready, we’ll seamlessly transfer them to your local entity or to your preferred licensees. ​

Your Virtual Regulatory Affairs Office

 

Drugs | BioPharmaceuticals | Medical Devices | Botanicals | Cosmetics | Nutraceuticals | Functional Foods | Dietary Supplements Medical Purpose Foods | Ayurvedic-Homeopathic-Unani Drugs

❱ ❱ Regulatory Reviews of Product Claims, Labels, Package Inserts, Advertisements, Marketing Material

❱ ❱ Regulatory Updates & Intelligence

❱ ❱ Registration Strategy

Regulatory Classifications of products at the intersection of Drug-Food, Drug-Cosmetic, Nutritional Supplement-Functional Food etc.

❱ Technical Dossier Writing

❱ Electronic Dossier Publication

❱ Maintaining Licenses and Technical Dossiers

❱ In-Country Representation

❱ Holding Marketing Authorizations

❱ Marketing Authorizations

❱ Regulatory Liaison

❱ Consumer Feedback Management

 

❱ Human Intervention Studies

❱ Outcome Studies

❱ Quality of Life Studies

 

❱ Training Sessions for Regulatory Affairs Executives, Marketing Teams

 

❱ GMP Audits & Training​

New York, USA | Toronto, Canada | New Delhi, India