International Laboratory Directories

Standards / Methodologies:

We offer a full range of regulatory affairs service from strategic planning and meeting with FDA to electronic submissions.

● Strategies planning and guidance throughout the regulatory submission process

● CMC section development & preparations

◦ Writing CMC (Module 2 and 3 sections) for drug products and drug substances

◦ Writing reports for completed studies

● Preparation of dossiers and submissions for DMF, IND, NDA, ANDA and BLA

● Preparation of required amendments

● Preparation of required Post-approval change supplements (PAS)

● Special meeting request and scheduling

● Meeting briefing package preparation & submission

● Critical review of prepared submissions

● Drug product labeling preparation

● Drug product registration and listing

● Facility registration

● Gateway set up for clients

● Electronic submissions of dossiers

● Helping clients to resolve their electronic submissions issues when they have in house publishing tools