Expertise
The team possess vast expertise in the fields of development, manufacture, regulatory affairs, regulatory compliance and GXP inspections for biologically derived and biotechnologically produced medicinal products. Products covered and examples of successfully finished projects provide an insight into our activities.
- Products covered
- Projects covered
- Clients
- Vaccines
- GMOs
- Blood products
- Recombinant proteins
- Recombinant antibodies
- Cell therapies
- Advanced therapy products
- Medical device combination products
- Strategic Management: Strategic development of licensing routes
- Mergers and Acquisitions: Product and project assessments
- Due Diligences: Technical and Management Audits
- Project management
- Scientific advice at various authorities in Europe and at the US FDA
- Clinical Trial Applications: Project management for compilation and submission
- Investigational Medicinal Product Dossier (IMPD) compilation
- INDs: Project Management and compilation of documents for several biopharmaceutical products
- Orphan Designation Application: submission and maintenance process
- Applications for market approval following the Centralised and Decentralised Procedure in Europe
- Variations of Market Authorisation: compilation and submission
- Renewal: compilation and submission
- GMP audits at various contract manufacturers
- GCP audits at various sponsors
- Medical Device development
Our clients are renowned micro, small and medium-sized biotech companies as well as large pharmaceutical companies. The following chart provides a selection of successfully accomplished projects:
| Client Type | Country | Project |
| Large biotherapeutic company | USA and Germany | Interim Management of the Regulatory Affairs Department to set up of the affiliate in Germany as European Headquarters |
| Medium-sized biotherapeutic company | Germany | Development of medical device with biological component |
| Large vaccine company | Germany, Switzerland | Compilation of several dossiers for vaccines |
| Large pharmaceutical company | France | Renewal and license transfer for a biotech product |
| Medium-sized biotech company |
United Kingdom | Compilation of a Biologics Master File for a recombinant protein for FDA submission |
| Micro biotech company | Germany | Development of a GMO vaccine up to clinical trial phase I and II |
| Small biotech company | Germany | Development of an antibody construct up to clinical trial phase I |
| Small vaccine company | USA | Due Diligence and GMP Audits of contract manufacturers |
| PPTA | USA | GMP audits |