The Regulatory Affairs practice group of Qu Consulting helps clients with formalizing their regulatory strategy. Be it a decision to enter the highly developed and competitive U.S. market or to explore the challenges of developing Africa, our experienced team works closely with clients to advise them on the most efficient and cost effective regulatory strategy. We will advise clients on how to best steer through the regulatory minefield so as to ensure timely approvals for ANDA’s and DMF’s. We work with clients’ right from the stage of deciding the drug portfolio, research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising.
We also assist clients with drug listing issues in various markets and import alerts etc.
Some areas of our expertise are listed below:
- Regulatory strategy for 505(b)(2)’s
- Filing strategy for Day 1 launches and FTF’s
- Gap assessments of infrastructure, people, procedures & processes for the regulatory function.
- Regulatory Audit to ensure total compliance.
- Regulatory strategy for market entry.