Magid-Haffner Associates, Inc. has the capabilities to assist your company to take a product from inception through development to USFDA approval.
USFDA
Magid-Haffner Associates, Inc. can act as the liaison for your company with the USFDA by providing guidance for your company
- With the submission of DMF, IND, NDA, ANDA and PMA documentation to the FDA
- Attendance at USFDA presentation and review meetings
- Expediting the final approval of your company’s Pharma, biotech or device products
Resulting in U.S. distribution and sales.
Agencies Outside the US
We have the capability and expertise to meet with international regulatory agencies, such as the MHRA, German BfArM and the Chinese SFDA, on behalf of our clients to expedite product approvals or resolve regulatory issues.
With associates located around the world, Magid-Haffner Associates, Inc. has the expertise to address our client’s concerns before they become regulatory problems and impact their supply chain.