Clinical Research Organization
Clinical Research a critical development phase of pharmaceutical industry has vast portfolio including innovation of new molecules, discovering new indications, drug design, dosage regimen, the assessment of devices for the administration of drugs and analysing the efficacy and safety of the product and determining equivalence against the reference product.
The criticality of the studies conducted depends upon the type of pharmaceutical formulation, the safety data provided plus the target therapeutic indications.
Regulatory Authorities have specific requirements for innovative molecules and to demonstrate their bio-equivalency with the reference product. In addition, Regulatory Authorities also prescribe certain specific requirements in terms of the formats for submitting all the data generated during clinical studies as part of the dossier submission.
We have a team of clinical and Regulatory experts to guide Clinical Research Organizations in Regulatory strategic consulting, Regulatory assessment or gap analysis, as well as to assist in the compilation and submission of such dossiers to various Health Authorities (HAs).
OUR MOTTO
- Design assistance for clinical studies in the preparation of study protocols and reports for clinical studies for all types of formulations for INDs, NDAs, BLAs, ANDAs, MAA for Global markets.
- Stage-wise compiling and submission of the entire dossier for biologics, innovations and generics including the quality, efficacy safety and administrative information to Health Authorities across the globe
- Assistance in justifying waivers for bioequivalence (BA/BE) studies and for performing those specific studies if not specified by the health authorities
- Compilation of the Common Technical Document (CTD) sections
- Life cycle management of the product related to a clinical point of view (medical enquirers, Periodic PADER submissions, ADE report submissions, Annual reports in addition to the review and compilation of the PSMF.