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Regulatory Expertise You Can TrustCommitted to Compliance, Quality, and Supply Chain Integrity

At Wessex Fine Chemicals, regulatory compliance is at the heart of everything we do. Since the implementation of the Falsified Medicines Directive (FMD), we have welcomed the increased regulation and accountability brought into the distribution of active pharmaceutical ingredients (APIs). We operate with full transparency, professionalism, and a deep understanding of both our responsibilities and yours.
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Understanding Your Regulatory NeedsWe’ve Got You Covered.

We don't just focus on our own compliance, we understand our customers' regulatory obligations too. Whether you’re preparing for a regulatory inspection, submitting a license application, or adding a second source for an API, we’re here to help. We will only ever propose a manufacturing source we’re confident meets your regulatory and quality expectations. We proactively provide:

Certificates 
of analysis

GMP and GDP 
statements

Regulatory 
declarations

Change control 
support

Full product traceability 
documentation

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Fully Aligned with MHRA & GDP GuidelinesEnsuring API Supply Meets Regulatory Expectations

We have been registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA) since 2013 as Importers and Distributors of Active Substances. Following the introduction of the EU Good Distribution Practice for Active Substances (GDP) in 2015, our Quality Management System is fully aligned to the guidelines.

Our written procedures cover every operational detail, supporting traceability, documentation, handling, and storage — ensuring every product we supply complies with current GDP standards.

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Built-In Supply Chain SecurityExpert Guidance on Pharmaceutical Legislation

Supply chain security is a core part of our service. We understand the critical role we play in maintaining the integrity between GMP environments — from manufacturer to end-user. We maintain:

  • Written handling agreements
  • Secure MHRA-registered API storage
  • Product-specific supply chain maps

But it’s also about relationships. We maintain long-standing, personal connections with logistics staff at API manufacturers and work with approved third-party logistics providers who understand the sensitivities of handling pharmaceutical products.

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Approved Suppliers

API supply is a process, not just a deliveryWe understand the whole process.

  • Phone: 01233 659558
  • Email us using the contact form below.
  • Address: Blackthorn House, Bridge Road, Ashford, TN23 1BB, UK

Contact Us

We’re here to support your pharmaceutical ingredient needs. Whether you’re looking for a specific API, need guidance on regulatory requirements, or simply want to discuss a potential project, our experienced team is ready to help.

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