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. ​

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Your Virtual Regulatory Affairs Office in New Delhi, India

Regulatory Affairs Services in the Domains of:

Drugs & Cosmetics Act | Drugs & Magic Remedies (Objectionable Advertisements) Act | Food Safety & Standards Act

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

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

❱ ❱ Regulatory Updates & Intelligence

❱ ❱ Registration Strategy

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

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❱ Technical Dossier Writing

❱ Electronic Dossier Publication

❱ Maintaining Licenses and Technical Dossiers

❱ In-Country Representation

❱ Holding Marketing Authorizations

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❱ 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​

Product Registrations in India & South Asia

We can facilitate your Business Plans for an emerging $35b Pharma Market! 

Just the way we’ve navigated some of the global top 10 companies in pharmaceuticals (including biologicals), medical devices, cosmetics, nutraceuticals and botanicals.