Data management (a) Procedures used for data review, database cleaning, and issuing and resolving data queries. (b) Procedures for verification, validation and securing of electronic clinical data systems, if applicable. (c) Procedures for data retention. (d) Specified retention period. (e) Other aspects of clinical quality assurance, as appropriate. 1.9 Amendments to the clinical investigation pl ...

3. To enhance the communication aspects, CDSCO should ensure that the industry representatives, and other stakeholders have easy and open access to all the relevant regulatory information and are educated about the drug regulatory requirements, process involved in new drug development. 4. Similarly, CDSCO meetings including Pre-submission/ Post–submission/SEC meetings should be held as per the lai ...

THE FOOD SAFETY and STANDARD AUTHORITY OF INDIA (FSSAI) Plays a pivotal role in ensuring food safety and hygiene standards across the country. Some of the key functions of FSSAI include laying down rules for food safety and quality standards to ensure the production, distribution, and consumption of safe and wholesome food. Accredited Consultants Pvt Ltd (ACPL) serves as a regulatory consultant, ...