Pharmaceutical Regulatory Affairs Services

Simbec-Orion delivers a full range of Regulatory Affairs services for the global pharmaceutical industry

Supporting your strategy

We deliver a full range of Regulatory Affairs services for the global pharmaceutical industry across the complete product life cycle. We have invested in the Cortellis Regulatory Intelligence database to support your pharmaceutical regulatory affairs strategy.

Simbec-Orion has built a robust regulatory strategy aiding fast study approvals and setup. You will be fully supported by an experienced team that can facilitate rapid contact with Regulatory Health Authorities, Ethics Committees and Notified Bodies during the development and maintenance phase of your clinical trials and clinical investigations.

We have strong and well-established relationships with the Regulatory agencies, and are ideally placed to support with preparation, conduct and reaching client objectives of face-to-face meetings with the pharmaceutical Regulatory Health Authorities for scientific advice / protocol assistance.

Regulatory Services

The comprehensive portfolio of pharmaceutical regulatory services provided by our scientific experts includes:

  • Regulatory submission experience in
    • First in Man and Phase I-III Patient studies with complex biological products & radiopharmaceuticals
    • Medical Device Clinical Investigations
    • Drug-Device combination studies
  • Clinical Trial Applications (CTAs) in more than 30 territories
  • Voluntary Harmonisation Procedure (VHP) submissions
  • Certified translations and back-translation of clinical trial application documentation into multiple languages

Continued…

 

  • Marketing Authorisation Applications (MAAs)
  • Strategic Regulatory planning
  • Due diligence / gap analysis on regulatory documentation
  • Technical advice on Chemistry Manufacturing Control (CMC),
  • Preparation and conduct of face-to-face meetings with regulatory authorities
  • Paediatric Investigational Plans (PIPs)
  • Orphan Drug Designation (ODD)

If you would like to connect with a regulatory expert, we would be delighted to discuss your requirements in greater detail. Please contact us.

Let’s collaborate

If you think we could be right for you, get in touch.

Submit an RFI/RFP