Clinical Regulatory & Quality System

At Romeo Life Science, we provide a wide array of regulatory services to meet the needs of medical device, pharmaceutical, and biotechnology companies.

Regulatory

We have experience in regulatory document preparation and management of client-focused projects. Our team of experts is equipped to guide clients through every stage of the product lifecycle, from research and development to successful launch, ensuring strict adherence to regulatory standards and timely approval.

Medical writing

Medical writing in clinical trials refers to the preparation of comprehensive documents that are required in clinical research. We prepare Study Protocols, Clinical Study Reports, Patient information sheets, informed consent forms, Investigator’s Brochures, IMPD, Common Technical Documents (CTD), and Scientific communication materials (such us marketing and training materials) n accordance with the guidelines set by regulatory bodies.

GxP & Quality

We are committed to helping organisations to implement a top-notch quality system. This system is designed with a holistic strategic approach to meet all GxP regulatory requirements in every facet of your operations. By doing so, we strive to mitigate potential risks, enhance resource efficiency, and ensure readiness for inspections and audits.

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