RAAJ GPRAC TEAM provides end-to-end services in this segment – starting from protocol preparation of various clinical study documents – both essential and non-essential, clinical study documents review, CRO/CMO identification, selection and qualification, various stakeholder regulatory submissions, study approvals management, study regulatory obligations, pre-study and post study audits, study related regulatory reporting, study report review and final study report submission to the regulator. We act as a Helping Hand to CRO’s/CMO’s Every Clinical Evaluation Plan that we create balances regulatory, clinical, and business risks and objectives.

We have a set of reliable, industry experts who assist our clients to collaborate the perfect CRO for their needs.

We cover everything under one roof for all your regulatory issues, beginning from filing till approval. We offer cost effective deliverables with accuracy and precision.

Services pertaining to CROs/CMOs
  • Clinical protocol development, creating Clinical Evaluation Reports (CERs), and integrating clinical operations into the Quality Management Systems (QMS) of companies.
  • Formulation Development (QbD), Support for Clinical Trial
  • BA/ BE study ,Toxicity Study.
  • Support in Product Development and Technology Transfer
  • Pre-market and Post-market Clinical Requirements
  • Post Market Clinical Follow up (PMCF) protocol
  • Review of clinical data to evaluate appropriateness for approvals
  • Clinical protocol and report as per ISO 14155 and Good Clinical Practice (GCP)
  • We ensure that the PSURs are filed thoroughly so as to support the pharmacovigilance system.
  • Adverse incident Reporting & Management and product recall support as part of Product safety reporting, Query management, PSUR Writing & Submission activities.
  • Clinical operations procedures to set up in house clinical studies
  • Creation of Scientific Publication Dashboard
  • Post market surveillance strategy and execution, Complaint handling.