Case Studies


  1. A Vendor Qualification Audit for Data Management and Pharmacovigilance Services

    2. One of the leading US companies dealing with drugs and devices wanted to perform a vendor qualification audit at a large CRO/IT services provider in India for Data Management and Pharmacovigilance. The client hired ComplyWell Solutions to perform the audit at a short notice and then to manage the CAPA process. The audit required to use different approaches as it involved the evaluation of processes used for different models (e.g. functional service provider and project-based services). ComplyWell Solutions provided an effective and efficient strategy for the client to conduct the vendor audit.

  2. Vendor Qualification Audits for Bioequivalence Centers

    3. A well-known European generics firm wanted to review their BE vendors in India for all the activities carried out by the vendors including bioanalysis and biostatistics. They selected ComplyWell Solutions due to the expertise in dealing with global customers while having the understanding of local regulations and practices.

  3. A Training for Regulatory Inspection Readiness

    4. The Indian affiliate of a multinational pharmaceutical company wanted to train the staff on the inspection process by regulatory authorities. As the Indian regulatory authority may also start sponsor inspections soon, the client wanted to make the staff aware of the inspection process and train them on good hosting practices for inspections by different regulatory authorities. ComplyWell Solutions took up the challenge and conducted the training and an intense review of several studies keeping in mind the Indian and global regulatory requirements. A comprehensive questionnaire prepared in advance helped to review several studies and sites in less than a week’s time during the training. The compilation of the lessons learnt from the exercise made the training very effective for the entire team and helped the client organization in making the team inspection ready.

  4. Strengthening the quality systems

    5. A large pharmaceutical firm wanted to strengthen their quality systems and processes. ComplyWell Solutions helps them on an on-going basis to review and update their processes, incorporate new aspects to improve the quality systems and make the processes comprehensive. The intent is to make the processes clear and robust using the global experience of ComplyWell Solutions, which can enable smooth conduct of clinical studies in different therapeutic area and geographies.