- Drug development phases (I-III):
- Clinical Trial Authorisation (CTA) applications; IMPD; IND
- Orphan designations
- Pediatric Investigation Plan (PIP)
- Scientific Advices; Briefing books
- Regulatory strategies in drug development, MAA and marketing plans
- Writing CMC documents
- Preparing of high quality regulatory documents
- Review of all scientific documents (CMC, non-clinical, clinical)
- Answering CTA deficiency letters
- Marketing Authorisation Applications (MAA):
- CP
- MRP/DCP/national
- Review and input to all labeling components
- Scientific advices
- Review of and input to all scientific documents and dossier components
- Answering MAA deficiency letters
- Supervision CTD/eCTD process
- Maintenance and LCM:
- Variations
- Answering deficiency letters
- Justification of change controls in the light of regulatory status globally
- CMC: Writing/updating/reviewing dossier; tech transfer; global state of the art compliance checks
- EAEU harmonisation (e.g.; former CIS countries)
- Indication expansions
- CMC line extensions
- Renewals/PSURs
- Creating/update labeling components acc. to QRD, CCDS
- Implementation of Risk Management Plan (RMP)
- Creation and revision of educational material to HCPs and patients
- Review of and input to all scientific documents
Further services:
- Building up RA divisions from scratch
- Interim RA management
- RA contact point for internal and external stakeholders
- MAH mergers incl. relocations
- Leading global RA staff and project teams
- Trainings to interdisciplinary teams
- Setting up user and functional unit, SOW requirements re business with partners
- Translations