Services >> Regulatory Services

CEERI provides regulatory services to sponsors and institutions in several regulatory areas:

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  Regulatory consultation on FDA, GCP, HIPPA compliance

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  Informed Consent design, protocol writing

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  Preparation and Filing of Investigators initiated IND/IDEs

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  Safety reporting to regulatory bodies

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  Clinical study reports

CEERI also prepares, submits, tracks, and maintains clinical trial applications to the regulatory authorities and reviews the clinical trial documentation to ensure compliance with all applicable GCP and regulatory guidelines.

Our regulatory affairs specialists are working closely with the monitors to ensure that safety information is appropriately collected, evaluated, and reported, including serious adverse events and other significant safety events.

At CEERI, we manage and compile the documents required for pharmaceutical regulatory affairs, IND and NDA submission. The submission involves all the documents containing the details of the new drug and clinical trial.

Our staff offers best solutions to meet all kinds of challenges for pharmaceutical, biotechnology, diagnostics and CRO industries.