End-to-end Marketing Authorisation Holder Services

We offer complete MAH services for companies without a physical presence in the EU or UK. As your local MAH, Integral Pharma Solutions takes full responsibility for your medicinal product, ensuring compliance with all national and regional regulations.

Regulatory Affairs

Our team of regulatory experts ensures that your products meet all legal and procedural requirements across the EU and UK markets. We handle the complexities of regulatory submissions so you can focus on bringing your products to market.

Pharmacovigilance

We offer a full end-to-end pharmacovigilance system including EU QPPV, PSMF, signal management, local PV and literature monitoring.

Quality Assurance

We provide robust quality management services to ensure your operations comply with all MAH requirements for GxP. We also offer QP batch release, batch testing and audits.

See our Blog post, which outlines the complexities that can be avoided by partnering with Integral Pharma Solutions.