Some of our clients develop orphan drugs or adapt already marketed drugs for orphan diseases or for paediatric use.
We help our clients make new innovative drugs available to patients as quickly as possible at an optimized cost.
For Creapharm & Sodia’s staff, quality is a state of mind, reflected in rigorous application of GMP and GDP guidelines, but above all, in the consistent dedication and commitment of all employees to an ambitious quality policy.
We are duly authorized by France’s regulatory agencies for human medicinal products and veterinary products (ANSM / ANSES).
We provide 100% traceability from receipt to shipment. All pharmaceutical steps are closely monitored using a barcode tracking system and specific software (Cristal and Gexpec) developed and validated for clinical trial manufacturing, packaging and distribution.
Our pharmaceutical expertise is based on a strong team of managers and specialists: graduates, engineers, and scientists qualified to PhD and PharmD level, including Qualified Persons, account for over 40% of our staff.
We pride ourselves on having progressively built up and retained a team of highly professional specialists, on both the management and the technical sides.
Our experienced project managers work closely with our clients to ensure that each IMP packaging is practical and well-suited to hospital or ambulatory use. They are also able to produce innovative customized patient kits, tailored to the design and complexity of the clinical trial protocol in question.
Every day, our QPs perform the pharmaceutical release of clinical batches packaged and / or distributed by us at the request of our clients.
They also manage the QP release of clinical batches manufactured in non-EU countries, imported either in bulk, for labelling and packaging, or ready to ship to investigational sites.
Depending on the country of origin and the products in question, our QPs evaluate the steps and the controls to be performed for EU certification (manufacturer audit, batch record review, quality control, etc.).
Constant adaptation to evolving pharmaceutical needs
Customization and partnership: not just words, but a permanent state of mind
More than a partner, a member of our clients’ supply chain management team