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