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Regulatory services

Our regulatory knowledge at Medicorent Int. AB, in combination with our clinical operation expertise, enables us to support you according to your specific needs and applicable regulatory requirements.

It is essential to develop a plan for your regulatory strategy early on during drug, biologic and medical device development. The regulatory plan is a strategic tool for being prepared and understanding the full regulatory picture from early development to market approval and post-marketing.

We can be your partner for regulatory activities, providing the right service at the right time by asking the relevant questions. Medicorent is also part of an established network of experts that can be consulted if needed. Let Medicorent support you in identifying key challenges that may arise and interacting collaboratively with regulatory authorities.

Expert regulatory services

  • Clinical regulatory expertise and guidance

  • Clinical quality management systems (QMS)

  • Compiling and submission of the product dossier to regulatory authorities

  • Responding to inquiries from regulatory authorities

  • Custom training for investigators and site staff regarding regulatory guidelines

  • Safety reporting and periodic literature review

  • Preparation of regulatory documentation such as the Investigator’s brochure (IB); clinical study protocol (CSP)/clinical study report (CSR) for drugs and biologics; clinical investigation plan (CIP)/clinical investigation report (CIR) for medical devices (ISO 14155); and clinical performance study protocol (CPSP)/clinical performance study report (CPSR) for IVDs (ISO 20916).

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