Services Offered
Regulatory Submission - Filing Expertise
The ability to understand the filing requirements necessary to bring products to market in the global arena is an essential requirement for a global regulatory consultancy We have particular expertise and success in the most challenging filings a pharmaceutical company can face. These include New Drug Applications (NDA) in the U.S. or Marketing Authorizing Application in the EU.
• IND/CTA
• NDA/MAA
• International Applications
• DMF
• PMF/VAMF
• ANDA
• Abridged Applications