Phase ON

Regulatory Affairs

Regulatory Affairs and Independent Ethics Committee submissions

We understand the critical importance of regulatory aspects for drug development program. We have dedicated team of regulatory affairs experts who is responsible to liaison with regulatory agency to navigate the complete and accurate regulatory approval process for conduct of clinical trial. The Regulatory Affairs Team consists of individuals having in-depth knowledge of regulatory guidelines and pathway for DCGI as well as FDA, EMEA and ANVISA. The team stay updated with all the changes and modifications taking place to current regulatory guidance and most recent version of guidance. We can help you to deal with emerging regulatory issues that arise during the product development program.

Our key services include:
i. Regulatory dossier compilation, including CTD and eCTD format
ii. Liaison for Regulatory Approvals to conduct a clinical trial
iii. Export NOC for biological samples for testing
iv. Obtain approval for Import license of drugs
v. Safety Reporting
vi. Product Registration for Marketing Approval

Service 1
Generic drug development

Generic drug development includes conducting Patient PK endpoint studies and also provide support to generic companies for the independent monitoring of the typical BA/BE studies.

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Service 2
Quality Assurance

Offers access to highly experienced Quality Assurance personnel to ensure compliance and quality in all clinical studies. We also provide standalone QA and audit support services to clients as needed..

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Service 3
Investigator Identification

PhaseOn leverages robust feasibility data and a trusted network of ICH-GCP trained KOLs and investigators across India to ensure accurate site selection across therapeutic areas.

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