Activities

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

Method/Technology transfer for getting US FDA 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 entities registration approval by Drug Control Committee.

Advising manufacturing and marketing department on regulatory requirements about promotional & packaging materials.

Providing strategic advice to senior management throughout the development of a new product.

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

Reviewing company practices and providing advice on changes to systems.

Liaising with, and making presentations to, regulatory authorities.

Negotiating with regulatory authorities for marketing authorization.

Specifying labeling and packaging requirements.

Preparing and submitting application for CPP/FSC for export.

Arranging certificate for internal price and supply.

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

Narcotics license, product registration and raw materials import permission.

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

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

New price (MRP) fixation approval from DGDA.

New Global products searching & sourcing for their raw materials for further analysis and go production for market launching.

Attending seminars of DGDA, DNC, DLS at any time as needed.

Pharmacovigilance report submission to DGDA as per need.

Imported products registration and renewal as per requirements of company.

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

All kind of Medicine & Model pharmacy license & renewal activities.