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.
- Marcel Wöllbrink Managing Director
From Lab to Patient: Pharmaceutical Development Navigated
Transforming Research into Remedies
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)
