Biological Services

Do you have a biologic, stem cell, or tissue that you would like to trial in Europe?

At Wellspring we have a dedicated team of biologists, GMP auditors and QP (IMP)'s who can conduct a full audit of your manufacturing premises and, subject to a satisfactory outcome, release your biologic with QP Declaration.

Whether your product is an Advanced Therapeutic Product, Combined Advanced Therapeutic Product; whether it is a stem cell, tissue or a form of cell therapy, Wellspring has the knowledge and experience to help with QP (IMP) Release into Europe.

We can also help with Clinical Trial Applications or legal representation in Europe if needed as well as creating a patient registry, which is regulatory requirement in Europe when trialling a biologic, cell therapy, stem cell, Advanced Therapeutic Medicinal Product (ATMP), combined Advanced Medicinal Product or medical device.

Patient Registry

A patient registry is a requirement to ensure traceability of every product. Our experienced database team can design coordinate and input all your existing product information so you can satisfy the MHRA, EMEA and other Competent Authorities requirements so, in the event of a recall, your products are fully traceable.
Moreover, as you move forward, such patient registries provide very useful post marketing and trending information.

Let Wellspring take the worry out of your trial.

Call us now on +44(0)1302 553020 Email us here.