Proven Reputation for High Quality and Integrity in Regulatory & Drug Development Consulting, with an Excellent Track Record in Successful FDA Applications
Contact
➤ LOCATION
8115 Maple Lawn Blvd
Suite 350
Fulton, MD 20759
☎ CONTACT
info@medeiraconsulting.com
(240) 621-0835
Scope of Services
Regulatory and drug development consulting / fda submissions
We provide integrated strategic, regulatory, and drug development consulting on drug candidates from pre-clinical research and pre-clinical IND…
FDA Communication Strategies and Agent Representation
We will represent our clients during negotiations with the FDA regarding drug development strategy, navigating through the FDA’s regulatory submission, review, and approval processes…
regulatory submissions and project management
We prepare and review drug submission packages, including pre-IND, IND, NDA/BLA, annual reports, and various FDA meeting information packages…
CGMP Manufacturing Compliance Consulting
We provide consulting services concerning Current Good Manufacturing Practice (CGMP) in the following areas…