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 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.

447 Broadway, 2nd FL #122

New York 10013, NY, USA.

3109, Saganashkee Lane,

Naperville, Illinois 60564, USA

58, Sudbury Court Drive

Harrow, Middlesex, HA1 3TD, UK

876, Udyog Vihar Phase V,

Gurgaon, Haryana 122016, India