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EU QP / Batch
Release Services

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Our EU QP Release and Quality Assurance Services

Our range of EU QP and regulatory services supports clients through every step of the compliance process, ensuring that products meet the highest quality standards.

Expert support for seamless compliance and market access.

Third-Party Site Audits

Comprehensive cGMP audits for EU and non-EU sites by our experienced auditors, including full GAP analysis for companies preparing for their first EU authority audit.

API Declarations

Assisting with Active Pharmaceutical Ingredient (API) declarations required for New Product Applications to European Regulatory Authorities.

Batch Certification & QP Batch Release

Ensuring that each batch complies with EU quality standards and is market-ready.

Supply Chain Logistics Planning

Our team supports clients in planning supply chain logistics from non-EU manufacturers to EU wholesalers. This service includes data flow coordination, invoicing processes, and managing product flow, ensuring a seamless transition into the European market.

Streamlining logistics to ensure smooth product flow into the EU.

  • Data and product flow: Coordinating all steps from manufacturing to EU distribution.
  • Invoicing routes: Simplifying financial processes across borders.

Additional Consultancy Services

Pharmadox offers consultancy services to help clients build and optimize their Quality Management Systems (QMS) and meet regulatory requirements. Our QPs and QA personnel are experienced in the following areas:

Expert guidance to strengthen quality and regulatory compliance.

  • QMS Creation & Optimisation: Development, validation, and optimisation of Quality Management Systems.
  • Regulatory Support: Assistance with filing applications and regulatory compliance.
  • Quality System Implementation: Ensuring robust quality control processes within organisations.
  • Auditing & GAP Reporting: Conducting in-depth audits and identifying areas for improvement.
  • Corrective and Preventive Action (CAPA): Implementing CAPA processes to address compliance issues effectively.

Expedited Market Access and Regulatory Confidence

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