Regulatory Support

 

We provide assistance to our clients in understanding the regulatory environment associated to their complex biological products. We can write relevant sections of the Clinical Trial Authorisation submission (Investigational Medicinal Product Dossier).

Our products were authorised for clinical trial by several national agencies (FDA, MHRA, ANSM, BFARM, etc.).

 

 

Quality

Our Quality Assurance team ensures that all GMP production and analytical operations comply with regulatory requirements. Our missions include the preparation of appropriate documentation in collaboration with R&D or analytical teams, the review and compilation of batch records, the release of GMP material by our Qualified Person as well as the audit and selection of suppliers.

To ensure the quality of its products, PX'Therapeutics complies with mandatory pharmaceutical quality standards and ISO 9001:2008.