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.

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 us