Regulatory Strategy – PharSafer® – Global Clinical and Post Marketing Drug Safety

Specialists in global clinical and post marketing drug safety

To help clients effectively navigate the complex regulatory landscape and meet their regulatory compliance obligations, PharSafer® support clients by preparing and submitting the varied regulatory filings world-wide, utilising scientific advice in development programmes for filing strategy; monitoring regulatory changes, and understanding the various mechanisms for obtaining licences for different product types e.g., herbal; traditional; generic; OTC; innovator.

Whether it be performing comprehensive regulatory compliance assessments, developing and maintaining the Global Product Labelling and Core Data Sheets or undertaking activities such as Licence extensions in new territories with new indications and formulations, our team has many years’ expertise to ensure our clients receive a first-class service.

Key Regulatory Strategy Services Offered:

  • Regulatory Strategy for Licence Construction, Scientific Advice & Submissions;
  • Global Licence Submissions;
  • Licence Variations;
  • Licence Renewals/Extensions;
  • Due Diligence for Licence Acquisitions;
  • SOP Writing;
  • Scientific Advice;
  • Core Safety Implementation;
  • Urgent Safety Restrictions;
  • XEVMPD Updates;
  • Licence Renewals;
  • Product Licence Extensions

One Stop Shop

At PharSafer®, we offer a breadth of services for clients around the world. View our full shopping list here to select the services you need to achieve your compliancy goals.


We’re with you at every step of the journey!


We’re with you at every step of the journey!