What We Do
Bellen Chemistry has over a decade of experiences and successful track records in developing compliant and clinical phase-appropriate analytical methods and validations.
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.
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
Fit for purpose process development to ensure successful scale-up and timely product delivery
Non-GMP and cGMP manufacturing for key intermediates, RSM, and final API
Specializing in the synthesis of complex chemical compounds to accelerate your drug discovery programs
No. 1, Caida 3rd Street
ShunYi District, Beijing 101300, China