Pre-clinical Research

Services scope:

Research of chemical API synthesis process, TCM extraction method, development and production of intermediates.

Research of drug preparation process

Development and improvement of quality standard

Research of stability

Testing of microbial limits and method validation

Expanded research of pilot-scale production, on-site verification is available

Research of TCM and TCM ingredients finger-print spectrum analysis method and development of quality standard

Development of therapeutic protein products

Extraction and isolation, ultrafiltration, purification of biochemical products, identification of virus and the inactivation

Development of physical chemical detection, testing of impurities and biological identification method, and the method validation, stability research

Improvement of drug quality standard, research of generics consistence evaluation

Solutions to customer’s technological difficulties and the technological directions

Designation, filtration, drafting and application of patent

Offering the service of consigned processing of pilot-scale production of reference comparison products, intermediates of drugs, formulation of general dosage form and health food

Why choose us:

Scientific management

The center has established a full set of rules and regulations for project management including duties and specifications for every step such as plan, argumentation, evaluation, examination, implementation, assessment acceptance, efficiency evaluation etc. We also established a timely and effective communication mechanism to insure the implementation of the project.

Outstanding team

The center has an outstanding and well-trained professional team. Directors of this team are all professional managers and very experienced in pre-clinical research and registration affairs. Team members have experienced numbers of pre-clinical research projects and they are also rich of experience. Meanwhile, we established effective training and evaluation system to improve our technical level and implement research in accordance with the laws and regulation of the state.

Rich experience

More than 10-year CRO experience and over 100 pharmacological and toxicological services, we have accumulated abundant experience and been keeping good relationship with the related government departments.

Excellent service

We target our clients’ benefit maximization and offer excellent services while charging comparatively low fees, in order to establish long-term business relation and win-win situation.

Lower fees: consignable company’s intervention in advance can hugely reduce the fees compared with purchasing CTA or new drug certificate.

Lower risk: consignable company’s participating in the whole procedure, knowing every details of the research can guarantee the feasibility of procedure and quality standard, avoid the risk of difficult to or impossible to produce qualified products which may be caused by purchasing CTA or drug production licence.

Good benefits: consignable company set up the project independently, designed customized, in line with the requirements of current developments, inosculates with management policies and distribution channel which is easier to become bigger and stronger.

Powered by CloudDream