Our team can offer guidance with clinical trial applications (IND/CTA), new drug submissions (NDA/ANDA) as needed in your project. Let us help expedite your regulatory filings and reviews. Regulatory services include:

• Regulatory strategy and helping with direct and indirect interaction regulatory agencies
• Helping with approvals on drug master files (DMF)
• We can offer guidance on regulatory submissions
• We can help in the Preparation of regulatory documents and filings
• We have in-depth experience working with international regulatory agencies (FDA, Health Canada and EU)