Regulatory Compliance

We are a global supplier of world-class quality Active Pharmaceutical Ingredients in full regulatory compliance for the US and European markets. In partnership with state-of-the-art manufacturing sites, DSC offers a wide range of API’s, as well as Finished product licensing, custom manufacturing and outsourcing services.  Our customers include 5 of  the top 10 Innovator “Big Pharma” Companies, 7 of the top 10 Generic  and Regional Generic Companies, Drug Delivery Companies, and Global and Regional Animal Health Companies.

Regulatory Affairs

The DSC Regulatory team has global experience in regulatory filings.
Highlights include:

• Received 20 FDA Approvals and maintain 45 Active DMF’s, 6 Active VMF’s
• Received 15 EDQM-COS approvals and 72 EDMF’s filed in 15 countries
• Achieved FDA, TGA and EMEA approvals on manufacturing facilities for both API and FDF
• Multiple successful re-inspections of API facilities over past 8 years
  • 14 FDA inspections
  • 2 BfarM (German) inspections
  • 3 TGA (Australia) inspections
  • 1 EDQM inspection
• Received first dossier approval in Europe during 2008

Regulatory services

• Translation
  • General Translation
  • Technical Translation
• Audit
  • Quality System Audit
  • Supplier Audits
  • Manufacturing Audits
• Compliance
  • Investigations
  • Change Control
  • Documentation Review
  • Internal Audits
• Submissions
  • FDA Establishment & Registration Listing
  • DMF Review & Preparation
  • Annual Reports & Amendments
  • CoS Preparation and Submission
• Training
  • cGLP
  • cGMP
  • Validation
  • Report Writing
  • document Management

 

 

 

 

 

regulatory Team

Dave Loomis

Laura Jin

 

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