Connecting the dots
Regulatory affairs and Quality Assurance
We help companies bring pharmaceutical
products and medical devices to market
Proud to be working with
leading pharmaceutical
and medtech companies
Solutions, Knowledge and Expertise
We offer flexible and adaptive solutions through consultancy services or tailored in-house support
Our highly qualified and experienced team are specialists within all aspects of Regulatory Affairs and Quality Assurance
What We Offer
Regulatory Affairs for Pharmaceuticals
Our team have comprehensive regulatory expertise to support the complete medicinal product lifecycle, from strategic early drug development to marketed products.
Regulatory Affairs for Medical Devices
Our team brings extensive expertise in regulatory strategy for medical devices, providing end-to-end support throughout the product lifecycle. Our services span from support in clinical investigations applications and regulatory planning to the preparation and submission of documentation for CE and UKCA marking. We also support post-market activities and lifecycle management to help ensure continued regulatory compliance.
Quality Assurance for Pharmaceuticals and Medical Devices
Whether you are looking to establish quality systems from the ground up, enhance the compliance of existing systems, or independently assess the quality of ongoing work, S-cubed’s Quality Assurance team has the expertise and experience to support your needs.
Other ways we can help
We offer associated services to support pharmaceutical and medical device development.
News
Q2 2026 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
EDQM publishes new guidance on reliance-based and fast-track assessment of CEP applications
Significant reduction in time to approval
Medical Device and In Vitro Diagnostics Regulations
Proposed amendments
Revision to the Guideline on the Chemistry of Active Substances
Effective September 2026