Regulatory affairs for biotech products
Biotechnologically produced medicinal products must meet special requirements for approval – all the more so if they are to be supplemented with medical products and are to act as combination products. We support both start-ups and established biotech companies in the development and market access of their biopharmaceuticals.
Our services for biotech products
We will accompany your biotech product through all stages up to the successful authorisation – and beyond. No matter whether you have questions about the implementation of GMP requirements, method development or your clinical development programme, or need the services of a Qualified Person (QP) for the release: we will help you create the necessary documentation and applications and will take care of contacting the authorities for you.
Product development
- Regulatory and strategic consulting
- Formulation development
- Implementation of the QM system and consultations on GxP aspects
- batch release accounted for by Qualified Person (QP)
- Supplier audits
- Comprehensive laboratory services incl. stability testing in accordance with ICH guidelines
- Preparation of briefing books and coordination of scientific advice discussions with the authorities
- Communication with the competent authorities
Clinical and preclinical development
- Coordination of our partners for preclinical and clinical development
- Creation and submission of IMPDs and INDs for clinical trials
- Manufacture, testing and release of clinical batches
Dossier and marketing authorisation
- Preparation and submission of dossiers for the investigational medicinal product (IMPD, IND)
- Communication with the authorities
- Consultation in marketing authorisation procedures
- Creation of marketing authorisation dossiers in eCTD format
- Applications for marketing authorisations and processing of RFIs and deficiency letters
- Project and process management
- GxP audits
Life cycle management
- Updating of dossiers, variations, renewals, line extensions)
- Quality management (e.g. audits, QMS update, PQR)
- Laboratory services (e.g. release testing)
- Pharmacovigilance
- Provision of QPs or QPPVs
- Review and release of advertising materials