Portfolios

Preparing submission of New Project (Cosmetics, Medical device, Pharmaceuticals-Human/Veterinary, Herbal, Unani, Ayurvedic) to DGDA for approval.

All kind of Model, Medicine shop & Depot new license & renewal.

Developing and writing clear arguments and explanations for new product licenses and license renewals.

Method/Technology transfer for getting USFDA approval on product Marketing Authorization by submission of ANDA (Abbreviated New Drug Application).

Preparing submissions of license variations and renewals to strict deadlines.

New molecules, medical devices entities registration approval by Drug Control Committee.

Undertaking and managing regulatory inspections for manufacturing license and the facilities available for new product registration.

Liaising with, and making presentations to, regulatory authorities.

Negotiating with regulatory authorities for marketing authorization.

Specifying labeling and packaging requirements.

Submit application & approval for CPP/FSC for export.

Managing drug testing report for local, export and institutional supply.

Preparing registration process for some exceptional products such as Vaccine, Insulin, Hormones and overall Biotech etc.

Submission of summary protocol for the lot release approval of different types of vaccine.

Price (MRP) fixation (new & increase) of medicines, medical devices approval from DGDA .

Pharmacovigilance report submit & approval of products.

All medical devices (Category A, B, C) registration, Import permission as per needed. 

Developing and writing clear arguments and explanations for new narcotic product licenses and license renewals.

Preparing submissions of Narcotic license variations and renewals to strict deadlines.

New molecules entities registration approval by Narcotics Control Department.

Undertaking and managing regulatory inspections for manufacturing license and the facilities available for narcotic product registration.

Liaising with, and making presentations to narcotics products control regulatory authorities.

Negotiating with regulatory authorities for IRC/ERC of narcotic products.

Narcotics license, product registration and raw materials import permission.

Developing and writing clear arguments and explanations for new veterinary product licenses and license renewals.

Preparing submissions of veterinary license variations and renewals to strict deadlines.

New molecules entities registration approval by Department of Livestock.

Undertaking and managing regulatory inspections for manufacturing license and the facilities available for veterinary product registration.

Liaising with, and making presentations to veterinary products control regulatory authorities.

Negotiating with regulatory authorities for veterinary products marketing authorization certificate.

Veterinary manufacturing license, product registration and raw materials import permission.