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Pharmaceutical and Analytical Development

Development of analytical methods for drug substances and products

  • Validation of analytical methods corresponding to Note For Guidance On Validation of Analytical Methods/Procedures
  • Pharmaceutical investigations in accordance with international pharmakopoes (e.g. Pharm.Eur., USP, BP)
  • Implementation of analytical methods published as a monograph in the Pharmacopeia (GMP).
  • Conducting lab-to-lab transfers for the purpose of implementing methods that are part of the marketing authorization dossier
  • Stability testing of drug substances and products corresponding to Note For Guidance on Stability Testing
  • Conducting forced degradation-studies
  • In-use stability testing of human medicinal products (CPMP)
  • Stability testing of biotechnological/biological products corresponding to Note For Guidance On Quality Of Biotechnological Products
  • Storage of drug substances and products in climatic zones I to IVa / IVb and under accelerated conditions (CPMP/ICH)
  • Photostability testing of drug substances and products (CPMP/ICH)
  • Identification and isolation of degradation products and impurities in drug substances and products.
  • Biopharmaceutical testing of drug products according to Guidance for Industry
  • Analytical testing and confirmation in accordance with ยง14 AMG (signed by head of quality control, AMG)
  • Analytical release of starting materials for GMP-manufacturing (API, excipients, intermediate products if appropriate)
  • On-going stability testing under GMP-conditions
  • Accompanying analytical testing for validation of manufacturing processes / Preparation of Process Validation Protocols and Report
  • Container Integrity-test

Specialized Development Analytics

  • Development of dissolution methods considering the Reflection paper on the dissolution specification for generic oral immediate release products and the recommendations of the Ph.Eur.
  • Manufacture of solid formulations on a very small scale for the purpose of demonstrating dissolution methods that are intended to be discriminatory.
  • Conducting in vitro dissolution studies for the purpose of the accompanying in vivo bioequivalence study, in accordance with the Guideline on the Investigation of Bioequivalence
  • Development of dissolution-methods for special products, e.g., solid dosage forms containing levothyroxine based on EMA/CHMP/176098/2020