At BOC Sciences, we understand the importance of quality control support from laboratory process development, production and regulatory data submission. Our dedicated scientists and quality control teams can provide our clients with a full spectrum of quality control services to support the analytical method development and research of your drug products from preclinical to commercial. The chemists and formulators from BOC Sciences are specialized in offering the support for routine activities from an operational standpoint. Furthermore, with advanced instrumentation, these team members can quickly bring our customers with solutions to bear on various problems including impurity ID, investigating OOS and aberrant results.
With decades of experience, our excellent experts provide comprehensive reports of research on quality for supporting the process development, drug substance and drug product manufacturing. Under the strict regulatory guidance, our team members specialized in supplying chain assurance for quality control of your drug formulations. The platforms of excellence endowed the BOC Sciences with the capabilities of providing high quality services including quality research of the products, consistency evaluation, IVIVC of the products and registration and submission.
Quality research of products has a significant effect on the drug development throughout the preclinical research including preclinical evaluation of a candidate drug substance, preformulation screening, formulation development and analytical validation. Our quality research is based on the characteristics of the dosage form and compound, and relevant guidelines. For quality research of your drug products, the products and services from BOC Sciences include the following: identification, assay, enantiomers, related substances, disintegration, dissolution, dissolution curve (12 units/lot) moisture or loss on drying, microbiological test, gels, ointments and creams: topical and rectal.
The mathematical link between dissolution testing and bioavailability can be defined as the concept of in vitro-in vivo correlation (IVIVC). To reduce the development time and optimize the formulation, IVIVC is often applied in the field of pharmaceutical development. Such correlation not only facilitates more effcient drug product development but also leads to improved product quality by an economical way. Especially for the development of BCS Class II API and BCS Class IV API, an excellent IVIVC of the products contributes to a reduced risk of BE failure and R&D costs.
The registration and submission services provided by BOC Sciences including data processing, compiling and translation of the registration dossier. We provide mainly five types of drug registration and submission: Application of investigational new drug (IND), Application of new drug application (NDA), Application of abbreviated new drug application (ANDA), Application of over-the-counter drugs (OTC), and Application of biologic license application (BLA).
The CMC experts in our department have decades of experience in the pre-formulation and formulation studies and are familiar with various ICH and CFDA regulations and guidelines. We have full confidence in providing reliable data used for the regulatory submissions for our clients.