Office:
103 Carnegie Center, Suite 103
 
Princeton, NJ 08540 USA
Phone:
(609) 799-0021
Fax:
(609) 497-9695

 

 

 

 - New Chemical Entities
 - Generic Drugs
 - OTC Products
 - Medical Devices

 

 

 

 

 



 


Our expertise in global drug development uniquely qualifies us as the provider of a variety of medical and regulatory services.

Medical and Clinical Consulting

  • Consulting on the Complete Product Development Program (all phases)
  • Reviewing and Assessing Clinical Protocols
  • Reviewing Safety and Efficacy Related Issues During Product Development
  • Adjudicating Clinical Data

Worldwide Drug Safety and Pharmacovigilance Services

  • Clinical Trial Safety Services
  • Post-Marketing Surveillance Services
  • Pharmacovigilance Consulting Services
  • EudraVigilance Reporting

Regulatory Support of New Chemical Entities

  • Global Regulatory Strategies
  • Regulatory Support of All Phases of Clinical Development (IND/CTA, import permits, export waivers, GCP auditing, etc.)
  • CMC (Chemistry, Manufacturing, Control)
  • Medical Writing
  • Labeling
  • Translations of Technical Documents
  • Coordination of Regulatory Certificates

In-licensing of Products for Marketing in the Emerging Markets

  • Assessment of Local Medical Need
  • Assessment of the Local Business Opportunity
  • Assessment of the Appropriateness of the Existing Documentation for an Approval in the Target Countries
  • Potential in-licensing of the Product
  • Serve as the Local Marketing Authorization Holder
  • Sales, Marketing, and Distribution Performed by a Local Distributor
  • Postmarketing Regulatory Maintenance

Regulatory Maintenance of Marketed Products

  • Life Cycle Management of Recently Marketed Products
  • Regulatory Maintenance of Older Products
  • CMC (Chemistry, Manufacturing, Control)
  • Post-Marketing Drug Safety & Pharmacovigilance
  • Labeling Updates and Harmonization of Labels
  • Product Transfers
  • Product Acquisitions (regulatory due diligence)
  • Company Mergers
  • Company Acquisitions (regulatory due diligence)
  • Regional Marketing Deals (co-promotion, co-marketing)
  • Coordination of Regulatory Certificates
  • Special Projects

Educational Activities

  • Training of personnel in pharmaceutical companies
  • Training of regulatory agency personnel from the emerging markets
  • Organizing meetings with drug development topics


 

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