Pharmaceutical Companies

Working to advance your regulatory approval process

 

Safis Solutions works with pharmaceutical companies around the globe to meet regulatory and quality standards.

 

Whether you are launching a new product or repurposing an existing drug for a new therapeutic use, we know what it takes to clear the regulatory hurdles and get to market.

 

 Prescription Drug

 

Setting Your Regulatory Strategy

 

The regulatory professionals at Safis Solutions have full life-cycle process knowledge at strategic and tactical levels. We can guide you through the various steps in the regulatory process for pharmaceuticals, including:

 

  • NDA submission (New Drug Application)
  • CTD submission (Common Technical Document)
  • Post market surveillance requirements

     


 

Helping You Gain Regulatory Approval Worldwide

 

With field experience in over 40 countries, our consultants navigate companies through the complex and continuously changing regulatory processes worldwide. Our specific experience includes:

 

  • European Union pharmaceutical regulations including Certificates of Suitability (CEP)
  • CFDA (China Food and Drug Administration) requirements

     

Also, as U.S. based company, Safis Solutions can serve in the role of an authorized representative for foreign companies looking to market their products in the U.S.

 


 

Working With Your Staff to Secure Approvals

 

For many pharmaceutical companies, Safis Solutions serves as an extension of the internal regulatory compliance team. We understand that your organization works fervently to ensure the quality of your product. We work with this same passion to ensure that your product gets to market as quickly as possible.