Analytical Services

Aenova offers comprehensive analytical services in the field of physical, chemical, and instrumental analysis of drugs, active pharmaceutical ingredients, and excipients.

Our extensive laboratory capacity and many years of experience make us a competent partner with a huge range of analysis solutions on offer. We have state-of-the-art equipment in the fields of physical, chemical, and instrumental analysis for testing drugs, active pharmaceutical ingredients, and excipients. Our leading competence centers provide a variety of services, including stability testing and the creation of stability reports, storage, and optimizing production methods.

When it comes to analytical testing, we offer a complete service:

  • Testing and release of active pharmaceutical ingredients and excipients according to monograph or customer specifications
  • Examination and approval for packaging or sale of solid oral pharmaceuticals from our own contract manufacture in accordance with certification documents
  • We are qualified to handle all types of controlled drugs according to national law
  • Stability testing
  • We plan studies designed according to ICH guidelines1 (long-term, ongoing, follow-up)
  • Storage in state-of-the-art climatic chambers with continuous monitoring of uninterrupted operation
    • Long term: 25°C and 60% RH, size 500 m2
    • Long term: 30°C and 65% RH, size 11 m2
    • Accelerated: 40°C and 75% RH, size 6 m2
  • Other climatic conditions available on customer request
  • Analytical testing
  • Evaluation and documentation
  • Development and validation of analytical methods
    • Development of analytical methods
    • Optimization of existing analytical methods
    • State-of-the-art methods: UHPLC/rapid resolution
    • Validation in accordance with ICH guidelines or customer requirements
    • Support and advice for the registration process
  • Do you already have an analytical method? We provide method transfer
    • Lab-to-lab transfer
    • Transfer of the method according to ISPE guidelines
    • On request, optimization of methods as part of the transfer
  • EU batch release approval
    • We import your product from third-party countries in accordance with the import license and issue the approval to put it on the market within the EU
    • Qualification of new sources for raw materials and other materials
    • Execution of GMP audits for manufacturers worldwide
    • Approval for the European market

1 ICH = International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (www.ich.org).