Regulatory consultation
Regulatory consultation: India & sub-continent, Central & Eastern Europe, Latin America
PhaseOn has experts on board to advice on the regulatory pathway for the product approval. We offer consultation on the regulatory requirements on the clinical development, dossier preparation and submission to the competent authorities in respective regions. Our close connections help us to track and respond to regulatory queries in a timely manner.
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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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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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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