What We Do

Development

Analytical method development and validation

Phase-appropriate analytical method development by dedicated quality assurance teams

Bellen Chemistry has over a decade of experiences and successful track records in developing compliant and clinical phase-appropriate analytical methods and validations.

How does it work?

Our analytical, research and development teams have a thorough understanding of latest regulatory requirements, relevant chemistry and analytical techniques which are critical in developing efficient, accurate, and reliable analytical methods.

The analysts interact closely with chemists to determine the exact requirement in order to swiftly develop 'fit-for-purpose' analytical methods. Special emphasis is placed on the first critical activity, sampling and sample preparation, for accurate estimation. The team has extensive experience in developing methods for chiral compounds, non-chromophoric compounds, as well as handling complex sample metrics and high molecular weight substances. Structure identification and confirmation of intermediates and impurities is an integral part of the analytical method development.

The analytical method is validated by a separate and dedicated team under QA guidance and supervision. The comprehensive analytical method validation protocols are prepared by the validation team and subsequently reviewed and approved by our quality assurance department. Relevant regulatory guidelines and work plans are closely adhered to during this process. The protocols are shared with the customer, for their review and approval. 

Why Bellen?

Experienced teams, well-versed in relevant global guidelines and customers expectations

Satellite analytical labs (within chemistry labs) for constant and closer interaction with chemists

Appropriate use of complementing analytical techniques

Common method approach for building efficiency within the analytical method

State-of-the-art equipment, tools and techniques

CONTACT US

Bellen Chemistry Headquarters

No. 1, Caida 3rd Street
MaoHua Garden
ShunYi District, Beijing 101300, China

  • Tel +86 (10) 6040 0362 (800)
  • Fax +86 (10) 6040 0323

Customer Service and Business Inquiry

  • Tel+86 (10) 6040 0362 (823)
  • Emailcustomer-service@bellenchem.com

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