Regulatory Servicing

We can help you to get required approvals from state FDA and CDSCO for any pharmaceutical product development and registration-related activities.

If you are an API manufacturer and looking for your product DMF filing globally we can help you with drafting and review of DMF as per country-specific regulatory requirements and help you in the submission and annual review process.

If you are a drug product manufacture and want to export your products in ROW or Regulated markets. we can help you for preparing country-specific dossiers, submission processes and help you to address regulatory queries or post-approval changes during the product lifecycle.

We have experts who can prepare strong CMC documents along with clinical and non-clinical bibliographic data for your regulatory filings.