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Regulatory Services

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

  • Regulatory Consultation on FDA, GCP, HIPPA Compliance

  • Informed Consent Design

  • Protocol Writing

  • Preparation and Filing of investigator-initiated IND/IDEs

  • Safety Reporting to regulatory bodies

  • Clinical Study Reports

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

Our regulatory affairs specialists work closely with clinical study 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 documents containing the details of a new drug or medical device and clinical trial.

Our staff offers solutions to meet various challenges for pharmaceutical, biotechnology, diagnostics and CRO industries.

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