Projects, Interim Management, Consulting, Coaching, Training in:

• Sourcing and Project Management

  • Products/ Regulatory Assistance/ Manufacturers/ Laboratories/ Generics/ APIs, etc.

• Quality Management

  • GMP, cGMP, GLP, GCP, GCLP, ISO 15189, ISO 17025, ISO 22000, HACCP etc.

  • Third Party Audit/ Independent QA Audits for Preclinical & Clinical Studies

  • Gap analysis of quality systems and advice on bridging the gaps/ Risk Management

  • Qualification/ Validation/ Computerized System Validation

  • Clinical Quality Assurance audits (Investigator Site, Phase 1 Units; CROs; Clinical Laboratories)

  • Database Audits, System Audits

  • Training courses - public and in-house on GLP, GCP, ISO 17025, ISO 15189, 21 CFR Part 11 etc.

• Toxicology & Laboratory Animals

  • Laboratory & Vivarium Planning, Set-up and Management

  • Animal Studies and Alternatives (in vitro Methods)/ Implementation of in vitro Methods

  • Regulatory and Research Toxicology/ Biostatistics

• R & D

  • New Drug Discovery/ Screening of compounds/ Natural products screening and claim substantiation

  • In vitro assays and in vivo efficacy in various disease models

  • Therapeutic target assay development and validation

• Approval of Pharmaceuticals, Chemicals (REACH), Biocides, Medical Devices, Disinfectants

  • Dossier Preparation

• Microbiology & Hygiene (Medical, Pharmaceutical, Food, Feed, Medical Devices)

...based on an international network and transcultural competence