Global Regulatory Services

We assist our clients in development of new products and data generation in line with country specific registration guidelines/regulations.

We provide guidance in development and preparation of R&D documents like AMV Protocols and Reports, Stability Protocols and Reports, Product Development Report (PDR) in CTD (ASEAN, EU or ICH) format.

We assist our clients in designing Comparative Dissolution Studies (with IVIVC) and in generating an acceptable data report for submission in the Health Authority. The summary of comparative studies of the product is required in the module 3.2.P.1 along with cross reference to the studies (with study numbers). It links the clinical formulations to the proposed commercial formulation and a successful correlation can assist in the selection of appropriate dissolution acceptance criteria.

We have collaboration with certified labs for analytical method development, method validation and transfer services. These labs are capable of performing validation as per ICH guidelines, acceptable to MOH/FDA of ASEAN, African, CIS, Latin American and Rest of World (ROW). We handle the queries from MOH/FDA related to validation well. As your research partner, we provide detailed protocol, chromatograms and report for method development and validation at the conclusion of each Validation project which is acceptable at MOH/FDA during product registration.

We assist our clients in planning their BA/BE studies, obtaining NOC for BE from the intended country of export, and in conducting Bioequivalence (BE) and Bioavailability (BA) Studies with well-known CROs.

We assist our clients in selection and identification of suitable Comparator/Reference Listed Drug product for the Generic applicants. Also, our team supervises and enables procurement/ import of Innovator Products required for the Comparative studies that helps in the generation of development data required for Dossier Registrations with MOH/FDA.