Helping you navigate the
Quality and Regulatory
complexities of pharmaceutical products
We support pharmaceutical manufacturers and distributors in building QMS aligned with EU standards, securing GMP licenses, and preparing regulatory dossiers. Our reliable, hands-on approach reduces regulatory uncertainty and inspection risks, giving your team clarity, compliance, and confidence. We provide End-to-end clarity that keeps your projects moving forward, so your products reach patients on time.
Our Services
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We help pharmaceutical companies prepare for regulatory inspections by performing a thorough gap analysis of their QMS. Our team identifies risks, proposes practical solutions, and supports their implementation—ensuring compliance with EU GMP/GDP standards and giving you confidence when facing auditors and regulatory authorities.
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We provide expert authoring of Module 3 (Quality) documentation to support both new marketing authorisations and lifecycle management activities. Our team ensures dossiers are clear, compliant, and aligned with regulatory expectations.
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We provide proactive regulatory intelligence, keeping clients updated on changing regulations and offering strategic insights for compliance. Our expertise includes writing and reviewing technical documentation to minimize regulatory risks. We offer comprehensive support for CE conformity and guide Quality Management System alignment with EN ISO 13485 for effective compliance. goes here
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Tailored importation and warehousing services, ensuring compliance with Good Distribution Practice (GDP) and providing Qualified Person (QP) and Responsible Person (RP) expertise. Serving as a site of physical importation and offering flexible short-term and long-term storage solutions, we collaborate closely with clients to meet unique requirements.
We Understand The Challenges You Face
Every update to EU regulations—whether medical devices or pharmaceuticals —creates new layers of complexity for pharma companies. It’s not just about meeting the letter of the law; it’s about building systems that inspectors can trust and that scale with your operations. Many teams feel overwhelmed by the effort required to align QMS, prepare documentation, and stay ready for inspections, especially when resources are limited. We’ve seen how this strain can slow down progress, increase risks, and take focus away from patients who are waiting for therapies.
Trusted expertise when it matters most
With more than 30 years of combined experience, our team has guided clients across pharma and medical devices through successful EU approvals and inspections.
You don’t need to face these challenges alone. Book a call today to discuss your needs and explore how we can support your compliance journey.
Move forward with confidence
Introductory Call
We start with a short call to understand your challenges and priorities. This is your chance to explain where you need support, and our chance to listen. No obligation, just a straightforward discussion to see if we’re the right fit.
Goal Setting and Project Plan
Together, we define the objectives and outline a clear plan of action. Whether it’s inspection readiness, dossier updates, or QMS setup, we establish timelines, responsibilities, and outcomes.
Focus on the Results
Our work doesn’t stop at advice. We help implement practical solutions and track progress against agreed goals. The result: stronger compliance, smoother inspections, and less uncertainty.