INTLX Ltd
Pharmaceutical Regulatory Consulting
Pharmaceutical Regulatory Consulting
Expert Regulatory CMC Guidance for the Pharmaceutical Industry
INTLX Ltd is a UK-based consultancy with over a decade of experience providing expert Regulatory CMC (Chemistry, Manufacturing, and Controls) support across a broad spectrum of pharmaceutical and biotechnology development programs. Founded in 2015, we specialise in high-quality, tailored input for projects involving New Chemical Entities (NCEs), Biologics, Peptides, and Advanced Therapy Medicinal Products (ATMPs).
Working closely with our clients to support all stages of product development and regulatory submission. Services include the preparation and critical review of INDs and IMPDs, comprehensive gap analyses and document support for NDA, BLA, and MAA submissions, and strategic guidance for regulatory interactions such as FDA and EMA Scientific Advice meetings.
Beyond documentation and regulatory strategy, INTLX also brings expertise in GMP compliance, providing support for Pre-Approval Inspection (PAI) readiness from the product perspective, helping teams navigate complex quality and regulatory expectations with confidence.
Over the years, built trusted relationships have been built with clients across the UK, Europe, the United States, and Asia, including a number of long-term partnerships with companies based in Japan. INTLX takes pride in delivering not just regulatory insight, but also pragmatic, collaborative support that integrates seamlessly into each client’s development journey.
At INTLX, scientific rigor is combined with a practical, responsive approach—ensuring that your regulatory goals are met efficiently and with the highest standards of quality.
Phil Smith is a seasoned expert in pharmaceutical regulatory affairs, with more than 35 years of experience spanning both industry and the UK medicines regulatory agency. As the Founder and Managing Director of INTLX Ltd, Phil brings a unique blend of strategic foresight and hands-on expertise to every project, supporting pharmaceutical and biotech organisations at all stages of development.
Throughout his career, Phil has led global regulatory CMC strategies and has been instrumental in integrating Chemistry, Manufacturing and Controls with Good Manufacturing Practice (GMP) requirements. His work spans a wide range of product types—including small molecules, biologics, peptides, and advanced therapy medicinal products—helping teams navigate complex regulatory pathways from early development to successful market approval.
Phil is recognised for his strategic clarity, practical problem-solving, and collaborative leadership style. He has held senior regulatory roles across a variety of organisations and has consistently provided valuable guidance on complex quality and CMC issues in both US and EU regulatory environments.
What sets Phil apart is his ability to combine scientific insight with a pragmatic, people-first approach. Known for his clear communication and calm, thoughtful manner, he fosters productive working relationships and helps create positive, high-performing teams. His passion for science is matched by a genuine interest in mentoring and supporting others in their professional journey.
Phil holds a Bachelor of Pharmacy degree from the University of Bath and continues to be driven by a commitment to regulatory excellence and innovation in life sciences.
Email: info@intlx.uk
Phone: +44 7588696777