Marketing Authorisation (MA) & Batch Release

MA Holding

As the Marketing Authorisation Holder, we take full regulatory responsibility for our products, ensuring compliance with all necessary requirements.

Product Launch

Comprehensive support for navigating regulatory pathways, preparing dossiers, and meeting submission requirements across diverse markets, including the UK and Europe.

Distribution

Seamless distribution to hospitals across the UK with options for same-day and next-day delivery, ensuring critical products reach their destinations promptly.

Life Cycle Management

Handling variations, renewals, transfers, and withdrawals of MAs.

Batch Release & Testing

Facilitating the release of medicinal products to the market, including coordination with certified testing laboratories.

Quality Assurance & Compliance Audits

Ensuring adherence to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.

Pharmacovigilance Support

Assistance with post-market safety surveillance and reporting requirements.

Regulatory Liaising

Acting as your direct liaison with regulatory authorities like the MHRA.