New Drugs and Clinical Trials Rules 2019, Explained for Sponsors
A sponsor's guide to the New Drugs and Clinical Trials Rules 2019: timelines, deemed approval, ethics committee rules, compensation duties and filing tips.

Expert knowledge, industry updates, and company news from Celesta Healthcare.
A sponsor's guide to the New Drugs and Clinical Trials Rules 2019: timelines, deemed approval, ethics committee rules, compensation duties and filing tips.
A section-by-section walkthrough of the ICH E3 clinical study report: what each of the 16 sections must contain and what regulatory reviewers look for.
How CDSCO regulates BA/BE studies in India: when bioequivalence is mandatory, the BE NOC export route, NDCT 2019 forms and realistic approval timelines.
Discover how India is becoming a global hub for veterinary and pet product manufacturing, with a focus on quality formulations and export opportunities.
A complete, step-by-step guide to starting a successful PCD pharma franchise business in India. Learn about the minimum requirements, investment, and choosing the right manufacturing partner.
Discover why India is the ideal hub to manufacture pharma products for export, covering essential certifications, documentation, and finding the right partner.
Learn everything you need to know about third-party pharma manufacturing in India, from its key benefits like cost savings and WHO-GMP quality to the step-by-step process of partnering with a contract manufacturer.
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