The Development Team consist of experienced regulatory affairs specialists having in depth regulatory knowledge within quality, non-clinical and clinical development.
By combining strategic, scientific and operational expertise, we ensure successful execution of regulatory submissions throughout the development phase up until and including the registration phase thereby supporting our clients’ key business goals.
The Regulatory Development Team:
- Can assist you in developing your global regulatory strategy
- Provide input to the CMC strategy, non-clinical strategy, and clinical strategy including review of non-clinical and clinical study protocols, and/or reports.
- Can help you identify the regulatory opportunities available for you and your development project and execute all relevant regulatory submissions in this context, incl.:
- Orphan Drug Designation applications (EU and US)
- SME applications (EU)
- PRIME (EU), Fast Track or Breakthrough applications (US)
- Can assist you preparing your Briefing Document and assist you in conducting scientific advices with Health Authorities, incl. Special Protocol Assessments
- Can manage all regulatory steps involved for your clinical trial, including:
- Preparation of Investigators Brochure and Investigational Medicinal Product Dossier in toto
- Preparation, compilation and submission of your Clinical Trial Application (CTA) or Investigational New Drug application (IND) and assistance with the response phase
- Maintenance of your CTA and/or IND with submission of Amendments, DSURs and Annual Reports
- Upload information to ClinicalTrials.cov and EudraCT, as applicable
- Can assist you preparing and submitting your PIP/PSP
- Can manage all regulatory steps involved in the registration phase incl.:
- Conduct of pre-submission meetings
- Preparation, review, and formatting of the regulatory dossier Module 1-5
- Compilation in eCTD
- Submission to Health Authorities in EU, US, CH, and CA
- Preparation and submission of responses to Health Authorities
- Can assist you in all areas of Medical writing, incl.:
- Preparation and/review of
- Module 2 documents, incl. overviews, summaries and tabulated summaries
- Study plans, protocols and reports (Module 4 and 5)
For more information about our team and the services we provide, please contact Sanne Elitha Svendsen, Head Regulatory Development.