Quality: CMC data requirements
BioVentures Consulting Limited has expertise in all aspects of chemical and pharmaceutical development; chemistry manufacturing and control (CMC). BioVentures Consulting Limited understands, through experience, how pharmaceutical development fits into the drug development process and how this information is included in the Common Technical Document (CTD) accompanying regulatory submissions. BioVentures Consulting Limited can advise on factors involved in dosage form design, dosage forms, biopharmaceutical and biotech formulation development.
BioVentures Consulting Limited can advise on product quality items, including quality systems, analytical testing and development, process validation, stability testing and design, including bracketing and matrixing. BioVentures Consulting Limited understands the importance of setting specification limits, and in-process, release and stability tests.
"BioVentures Consulting Limited understands the needs of the regulatory reviewer"
Quality aspects of a regulatory submission is presented in Module 3 and the Quality Overall Summary (QOS) in Module 2.3 of the Common Technical Document (CTD). BioVentures Consulting Limited can explain the legislation behind both Module 3 and the Quality Overall Summary and understands the needs of the regulatory reviewer in assessing these modules. BioVentures Consulting Limited is thus able to advise on the right level of time and effort to create the submission which also helps to reduce approval times. BioVentures Consulting Limited offers advice in the preparation of these key documents and in the interpretation of ICH Quality Guidelines.