Simbec-Orion delivers a full range of Regulatory Affairs services for the global pharmaceutical industry
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.
The comprehensive portfolio of pharmaceutical regulatory services provided by our regulatory 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
- EU Clinical Trial Regulation & the Clinical Trial Information System (CTIS)
- Voluntary Harmonisation Procedure (VHP) submissions
- Certified translations and back-translation of clinical trial application documentation into multiple languages
- Marketing Authorisation Applications (MAAs)
- Strategic Regulatory planning
- Orphan Drug Designation (ODD)
- Combining flexibility with technical and practical experience to find a solution tailored to clients’ needs
If you would like to connect with a regulatory expert, we would be delighted to discuss your requirements in greater detail. Please contact us.
Clients Say About Us
The people working at Simbec Orion are dedicated, very professional and they cover all aspects of clinical research. A team will be set up for your project, who will have a strong focus on your study in a very open minded and friendly atmosphere. The studies I have outsourced to Simbec Orion, have been successfully managed and performed. I will use Simbec Orion in the future and I can strongly recommend them to other pharmaceutical companies.
Tina Lidén Mascher, Head of Clinical Operations