- Drug development phases (I-III):
- Clinical Trial Authorisation (CTA) applications
- Orphan designations
- Pediatric Investigation Plan (PIP)
- Scientific Advices
- Regulatory strategies in drug development and marketing plans
- Writing CMC documents
- Preparing of high quality regulatory documents
- Review of all scientific documents (non-clinical, clinical)
- Answering CTA deficiency letters
- Creating of regulatory and scientific guidelines
- Interpretation of legislations and guidelines
- 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
- Justification of change controls in the light of regulatory status in different regions (EU/US/CA/ITC)
- Indication expansions
- Line extensions
- Renewals/PSURs
- Creating/update labeling components acc. to QRD (e.g., after CP), CCDS
- CMC compliance checks (GMP/site practices vs. regulatory documentation: EU, US, CA, ITC)
- Writing CMC documents
- 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:
- Interim RA management on- and off-site
- Building up RA divisions from scratch
- Leading RA staff and project teams
- Trainings to interdisciplinary teams
- Translations