Global Pharma Supply Chain & Regulatory Experts

PharmaSight International specialises in tailored regulatory compliance, pharmaceutical supply chain management, and global quality management solutions. Our team brings extensive expertise spanning regulatory strategy, clinical affairs, GCP, pharmacovigilance, product authorisations and GDP — covering the full product lifecycle from early development through to post-authorisation and commercial distribution.

Leveraging our expertise as former MHRA inspectors and seasoned regulatory professionals with deep involvement across the global supply chain, we provide unparalleled insights into GMDP compliance, regulatory submissions and strategic support for pharmaceutical companies and distributors worldwide.
With a strong global presence and offices in London and Dubai, PharmaSight International is dedicated to supporting clients worldwide, with a particular focus on the MENA region.

Our team of industry professionals brings hands-on experience across Good Distribution Practice (GDP), Quality Management Systems (QMS), international logistics, MAA/BLA/IND submissions, and EMA and FDA interactions. We deliver quality-focused, practical solutions to help clients navigate complex regulatory frameworks, optimise supply chain operations, and overcome the unique challenges of the pharmaceutical industry.

About us

PharmaSight: Professional GxP Consulting and Regulatory Services

As global GxP professionals, PharmaSight International helps pharmaceutical organisations achieve regulatory compliance while optimising their operations across the full product lifecycle. Our team of former regulators, inspectors, and supply chain experts brings in-depth knowledge of GDP, GMP, GCP, GLP, and GVP, underpinned by a strong command of regulatory requirements across the EU, UK, Americas, and MENA regions — including EMA, MHRA, FDA, WHO, UAE MOHAP, and Saudi FDA guidelines. With this expertise, we guide clients to achieve excellence in compliance, operational efficiency, and end-to-end supply chain management.

 

Our extensive experience across GxP disciplines and Quality Management allows us to offer a comprehensive range of services, including QMS development, inspection readiness, auditing, supply chain assessment, and validation. With GDP as a cornerstone of our practice, we also provide specialised support with pharmaceutical storage licensing, transport network management and validation, risk assessments, and freight forwarding. We further advise on the feasibility and regulatory compliance of medicinal product import and export through appropriately validated and authorised channels, ensuring supply chain integrity at every stage.

Our expertise

GxP and RA

As GxP professionals, we possess extensive knowledge and experience across Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP). We have implemented GxP-compliant frameworks across international organisations, considering local regulatory requirements from authorities including the EMA, MHRA, FDA, WHO, UAE MOHAP, and Saudi FDA. We can help you achieve and maintain compliance across your entire operation, ensuring the integrity, safety, and quality of medicinal products at every stage of the supply chain.

QMS Development

We can support you with documenting a comprehensive Quality Management framework bespoke to your business. We can assist you in the development of a QMS and unique SOPs that are not only GDP compliant but also work for your business.

 

Global regulatory compliance

PharmaSight specialises in helping its clients achieve regulatory compliance, ensuring that businesses in the pharmaceutical industry meet the global standards and regulations. We have experience in supporting pharmaceutical importers and exporters and dealing with regulators worldwide.

 

We can provide guidance in distributing pharmaceuticals across various territories such as the U.K., Europe, Americas, Middle East and Asia Pacific regions and assist you in developing compliant physical and financial distribution models.  

Testimonials

The mock GDP inspection performed by Shams highlighted key non-conformances in our GDP processes and helped us to implement swift corrective actions before inspection.

The QMS development service helped us establish a robust quality management system that enhanced our overall operational efficiency. Pharmasight helped to design and write our SOPs and implement training across our team who have since become more quality focused.

Using PharmasSight for their expert advice in distributing medicines globally was instrumental in ensuring we could get medicines to key clients across the Middle East. The guidance on exports, obtaining relevant permits from the Home Office and ensuring customs clearance in the region was invaluable.

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