Development Stage Regulatory Support
Diamond Pharma Services has extensive experience in assisting companies to navigate through clinical development. We provide a wide range of services including:
- REGULATORY GAP ANALYSIS AND DEVELOPMENT PLANS
- NATIONAL AND EMA SCIENTIFIC ADVICE MEETINGS
- PRIME APPLICATIONS
- ORPHAN DESIGNATION APPLICATIONS
- PAEDIATRIC INVESTIGATION PLANS
- CTA / IND
- MAA/ BLA/ NDA, eCTD SUBMISSIONS
We are specialists in providing bespoke cover to companies either via the provision of dedicated full time equivalent coverage, or ad hoc support.
The team work routinely with Sponsors to write associated dossiers including:
- BRIEFING DOCUMENTS
- INVESTIGATIONAL MEDICINAL PRODUCT DOSSIERS (IMPDS)
- INVESTIGATIONAL NEW DRUG APPLICATIONS (IND)
- INVESTIGATOR’S BROCHURES (IB)
Our staff are experts in liaising with clients and their CRO/CMOs to extract the information necessary to write dossiers from source documents. Over the last decade the team at Diamond have attended over a 100 scientific advice meetings and supported a wide range of EU national and centralised procedures. Diamond specialise in building bespoke teams for our clients whether it be for ad hoc strategic regulatory advice or a full regulatory programme to seek scientific advice leading to documentation preparation, CTA and responses to questions.