Need For Quality Regulatory Services

Over the past few years there has been significant changes and development in the Indian medical landscape

. There has been a growing demand for regulatory and auditing services in clinical trials and researches. All regulated markets give emphasis on the quality of clinical trial, whether it is prior to the trial, during the trial or after the trial.

According to most regulatory service professionals and Auditees, the audit process is uneasy, unpredictable and filled with uncertainty. In addition to that, the process preparation is frantic, tiring and time consuming. For several companies, the failure of any audit might not only be very expensive, but also concerning as in an industry that is the largest globally, the word of mouth becomes very crucial. The medical industry is huge and expanding, and at the same time very influential. Furthermore, there are several sites that are now participating in the clinical trials that comprises of numerous external players such as Central Labs, SMOs, translation agencies, and so on and so forth. Today the electronic data capture has completely taken over the paper CRF filing which needs the robust quality systems in order to proactively check the compliance at all levels.

Today several Indian CROs offers regulatory services and QA services that forms an essential element of their overall service portfolio. These CROs have conducted several audits from Indian as well as International regulatory agencies. There have been studies submissions have made to numerous countries as well. This apart some of the CROs have been sanctioned study submissions to places such as the Republic of Sudan, NPCB Malaysia and National Medicines & Poisons Board and MOH Israel. The wide range of services offered by them include the following:

* Formulation of regulatory strategies

* Compilation of the clinical trial application

* Submission and follow-up of the application

* Responding to regulatory agency queries

* Procurement of drug import licenses

* Procurement of NOC for export of biological samples

* Tracking of applications and approvals

* Safety Reporting

* Submission of Clinical Safety Report (CSR)

* Renewal of Import License

Every CRO in India has a dedicated team for audit compliance and regulatory services, that is supported by in-depth know-how of the local regulatory processes and efficient liaison with multiple regulatory agencies, ensuring the efficiency in clinical trial approval procedures.

by: Gladeyas

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