Most CROs in India today offer regulatory services that facilitate all the levels of Phase I-IV studies and other stages of drug development
. It is attained by offering interdisciplinary strategy planning to obtain the most efficient and effective regulatory way leading to regulatory authorizations. Most CROs utilize the experience of learned medical professionals and apply this learning in various projects. They also have an expert team who are able to manage a wide range of regulatory services and enables concerned sponsors to fulfill exigent timelines. CROs are able to help the sponsors attain regulatory approvals owing to their experience in and in-depth understanding of Indian drug control regulations.
In recent times, India has emerged as one of the most favorable destinations for clinical trials and researches by multinational pharmaceutical companies. The main reason for this is its high-end and advanced healthcare facilities and healthcare professionals, cost advantage, the size of the significant valid patient population to participate in clinical trials and the use of the English language in all documentation and as official communication with investigators, Ethics Committee and DCG (I) Office except for the patient document, (mainly Informed Consent Document) that needs to be translated into the local languages. In addition, advancement in the communication sector and information technology in India is a well-known fact and also that Indian research and data generation capabilities meet international standards and Indian data is accepted by all major medical conferences and journals. Based on the studies in India, other regulatory agencies are allowing the products to be marketed in their country.
For eminent CROs in India, regulatory services and QA consists of essential elements of the service portfolio offered to people. The dedicated team for audit and regulatory compliance are generally backed up by in-depth knowledge of local regulatory processes and an apt liaison with the numerous regulatory agencies that ensures efficiency in the clinical trial approval process.
Some of the services offered by the CROs are listed below-
1. Formulation of regulatory strategies
2. Compilation of the clinical trial application
3. Submission and follow-up of the application
4. Response to regulatory agency queries
5. Procurement of drug import licenses
6. Procurement of NOC for export of biological samples
7. Tracking of applications and approvals
8. Safety Reporting
9. Submission of Clinical Safety Report (CSR)
10.Renewal of Import License
Regulatory services offered by the CROs along with their clinical laboratory assists in medical studies that later on help in disease treatment and diagnoses and other crucial forms of drug development.