Over 50% of our clients have needed Regulatory Strategy advice to enable a successful licence submission and approval
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
