Regulatory Affairs & Marketing Authorizations
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
❱ ❱ 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
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.
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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37 Years of Partnering with BigPharma as well as Emerging Companies
based at USA, UK, EU, Japan, Canada, Australia & Singapore.
Operations across USA, India, Middle East, APAC & Australia.
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