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
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