Magid-Haffner Associates, Inc

As a global company we have associates that have regulatory expertise in the EU, US, Japan, India and China and can support FDA and EMEA submissions. We are the U.S. Agent for several foreign API companies and Magid-Haffner Associates, Inc. is located within one hour of the FDA campus in Rockville, MD.

Regulatory Expertise:

Magid-Haffner Associates, Inc. has provided guidance to clients

• By conducting FDA/EMEA International GMP Compliance Audits for API, sterile and non-sterile drug products.
• In submission of DMFs, ASMFs, INDs, ANDAs, NDAs and MAAs by our global associates.
• With Quality Assurance support for FDA Failure Investigations, CAPA Implementation, FDA-483 and Warning Letter responses, Quality Management, Quality Systems Development/Implementation, SOP Development and Stability Programs.
• By providing cGMP training customized for product and company specific applications.