Medicinal Product Services
We offer regulatory and medical support as well as clinical support for both human and veterinary medicines. Our key services include:
Strategic planning for product development
- Preparation or review of strategies especially for generic products
- Assessment of regulatory opportunities and risks
- Review and appraisal of the regulatory environment, the relevant guidelines, existing precedents and ongoing regulatory initiatives possibly affecting the process
- Preparing and arranging pre-submission and/or scientific advice meetings with European regulatory agencies
- Preparation of development plan for generic products
Support to the implementation, conduct and evaluation of clinical studies according to the relevant guidelines:
- Clinical study protocol and final study report according to ICH/GCP
- Study site selection
- Support in selecting and contracting a CRO
- CRO management
- Investigator trainings as needed (study procedures according to GCP)
- Clinical trial applications and ethics committee applications
- Other medical writing needs, i.e. draft publication
Active Substance Master File (ASMF) and Certificate of Suitability (CEP) Procedures
- Consulting services on ASMF (formerly European Drug Master File (EDMF)) and certificate procedures for active substances (CEP)
- Writing of ASMF based on client raw data
- Coordination of ASMF procedures
- Writing of the dossier including QOS, and coordination of application for CEP with EDQM
Registration Documentation
- Preparation of the dossier or parts of the dossier for marketing authorization and variation submissions in CTD or NTA format
- Writing of chemical-pharmaceutical dossiers (CMC, Module 3, Part II) based on client raw data
- Compilation of pharmaceutical-toxicological and clinical documentation
- Writing of quality overall summaries (pharmaceutical-chemical expert reports)
- Writing of non-clinical and clinical overviews (pharmacological-toxicological and clinical expert reports)
- Preparation of SmPC, patient information and labeling
- Preparation of Module 1 for different European countries
- eCTD capability
Marketing Authorization Applications (MAA)
- Preparation and submission of all types of MAA such as national, centralized (CP), decentralized (DCP) and mutual recognition procedures (MRP)
- Preparation of response documents to authority deficiency letters/list of questions
- Preparation and conduct of pre-filing discussions with authorities
Maintenance and Lifecycle Management
- Monitoring of due dates
- Follow-up post-approval commitments
- Preparation and submission of variations and extensions
- Preparation and submission of renewal applications
