Clinical Trials

QP Services

QP Services

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Qualified experts at your service

Conducting clinical trials is more complex than ever. Caligor can help, with expert consulting services designed to streamline and simplify a wide range of tasks. Key to our consulting services is the expertise of our team, including our in-house, licensed Qualified Persons (QPs). Their knowledge and experience can help ensure compliance at every step, freeing your team to focus on the business of product development.

We help you deal with the complexity of clinical trials, assisting with a range of value-added services, including:

  • QP certification—All pharmaceutical products destined for use in the European Union must be certified by a licensed Qualified Person (QP). Caligor’s team of QPs can provide the required clearances you need in a timely manner—whether you are accessing products from Caligor.
  • Trial application review—We provide expert review of your Investigational Medicinal Product Dossier (IMPD) and other applicable regulatory documents to ensure they are accurately and optimally completed, helping streamline regulatory review and avoid trial delays.
  • Batch manufacturing records review—We review manufacturers’ investigational product records to ensure accuracy, acceptability for the trial, and GMP compliance. We can also assist with batch expiry extensions.
  • Audits of manufacturing facilities—We perform audits of primary and secondary production facilities to ensure that they conform to GMP guidelines.
  • Trial optimization consulting—We can help support your success with a range of expert consulting services, from helping select the most appropriate product form for your trial to managing third-party vendors.
  • Customized solutions—We can provide tailored solutions for a wide range of requirements—from packaging and labeling to storage, distribution, and logistics.

Caligor’s team of consultants is completely dedicated to helping you achieve a smooth, efficient, and successful clinical trial. Let us show you the difference expertise can make.