Regulatory Affairs
Our key services in regulatory affairs include:
strategic advice:
- development strategies
- regulatory strategies for Europe
- pre-submission evaluation of technical data
- planning and handling of agency meetings (including preparation of briefing documents)
- due diligence for licensing projects
- regulatory intelligence
documentation:
- compilation of dossiers according to Notice to Applicants / Common Technical Document standard
- compilation of ectd
- Chemical-pharmaceutical dossiers (CMC, Module 3): technical writing of the complete part based on customers raw data
- Drug Master File: technical writing of EU Drug Master File
- Pharmacological-Toxicological and Clinical documentation: compilation of dossiers based on customers study results
- Preparation of SmPC's, patient leaflet and labelling
- Chemical-pharmaceutical Expert Reports (Quality Overal Summary)
- Pharmacological-Toxicological Expert Reports (Nonclinical Overview)
- Clinical Expert Reports (Clinical Overview)
- Literature search in all relevant databases
project management:
- We ensure that your applications and dossiers meet the relevant requirements and that the documentation is prepared in a timely manner.
- Follow up with customer's internal departments and with company's external partners
- On-site staffing and support can be provided
- We handle your national procedures as well as your EU procedures (DCP / MRP) from submission to approval.
- Our team of experts prepares answers to deficiency letters.
- Liaison with German (BfArM) and other EU authorities in all stages of the procedure
- We handle the logistics of your applications
Life cycle management / maintenance
- Triggered by EU guidelines it will be necessary in the future to provide more regulatory support for marketed products. Both for variations and for renewals state of the art documents are needed to keep your products alive. We ensure that your updates are prepared according to recent requirements.
- Export outside the EU:
We adapt your dossier to the needs of non EU agencies.
- Export outside the EU: