Pharmaceutical Development

WE GUIDE YOU THROUGH THE PHARMACEUTICAL DEVELOPMENT OF DRUG SUBSTANCES AND PRODUCTS, IDENTIFYING AND RESOLVING ISSUES TO HELP STREAMLINE THE PROCESS AND REDUCE TIME TO MARKET.

- Dr. Lutz Müller Head of Chemistry, Manufacturing and Controls/Chemist

Pharmaceutical Development

Our pharmaceutical development team has many years of experience and can support you in the following areas:

General

  • Set-up of development plans
  • Management of pharmaceutical development
  • Vendor selection and follow up of vendors
  • Support in GMP requirements for development programs, including those for investigational medicinal products and drug substances used during their manufacture
  • Interaction with competent regulatory authorities as required during pharmaceutical development (see regulatory strategy and implementation)
  • Special experience for the design of combined development programs in different regions (the EU, US, Japan, LATAM, India, China, and ASEAN)

Drug substance

  • Herbal substances and extracts
  • Chemical and semi-synthetic drug substances
  • Biological and biotechnological products
  • Selection of key starting material and GMP requirements in accordance with ICH Q11
  • Definition of key critical attributes of drug substances
  • Planning and follow up of analytical development and validation
  • Design for process development and validation
  • Preparation of stability programs
  • Review of DMFs/ASMFs

Drug product

  • Experience in a broad range of pharmaceutical forms and routes of application
  • Definition of formulation and manufacturing process development programs, including supervision and final review of results
  • Quality design and design space planning
  • Scale-up and process validation programs
  • Analytical development programs and review of validation protocols and reports
  • Production and analytical transfers, including on-site support
  • Selection of packaging materials and medical devices for administration
  • Stability programs for ICH and other regions, including supply chain requirements
  • Requirements for Investigational Medicinal Product (IMP) manufacture, analysis, and distribution

Documentation

  • Quality parts of IMPDs/INDs
  • Modules 2.3 and 3
  • Dossiers for applications for Certificates of Suitability (CEPs)
  • Drug Master Files/Active Substance Master Files (the EU, US, and Japan)
  • EU regulatory representative for DMFs/ASMFs
  • Quality agreements and other GMP documentation (site master files)

Have a question concerning Pharmaceutical Development? Contact Dr. Lutz Müller.