EU & UK QP Release

QP Release & Regulatory Support Services

Expert Qualified Person Oversight for UK, EU & Global Clinical and Commercial Supply

QP Release: The Seal of Approval

Ensure your investigational medicinal products (IMPs) are compliant, safe, and ready for clinical use with Eramol’s expert Qualified Person (QP) Release Services.

Eramol provides end-to-end regulatory support, batch release, and global IMP distribution, combining deep expertise with a seamless operational workflow.

Why QP Release Matters

The release of IMPs is a critical step in clinical trials. Qualified Persons (QPs) are legally accountable for ensuring that each batch of product meets GMP standards, regulatory requirements, and quality expectations before use in clinical studies.

Eramol QPs bring extensive knowledge of EU and UK legislation, as well as international regulatory frameworks, ensuring that every batch is released with the correct data, documentation, and approvals for its destination.

Eramol’s QP Expertise & Regulatory Support

Our QPs are fully qualified for UK and EU batch release, and their oversight spans the entire product lifecycle, from manufacturing to end-user supply.

Key responsibilities include:

Assessing GMP compliance across the supply chain
Participating in inspections and audits at manufacturing and distribution sites
Acting as a reliable regulatory contact for health authorities
Applying relevant legislation, including managing exceptions that affect IMP quality and safety
Overseeing complaint handling and product recalls
Providing guidance for third-country GMP declarations

Eramol’s QPs are integrated into the Project Management team, ensuring consistent oversight across clinical and commercial programmes.

Comprehensive QP Auditing Services

Eramol QPs are IRCA-trained lead auditors with global experience across:

Chemical & biological APIs
Sterile & non-sterile drug products
Biotechnological and ATMP products
Radiopharmaceuticals
QC laboratories, including data integrity audits
Packaging, labelling, and warehousing sites

We also partner with approved regional auditors to extend global auditing capacity.

Seamless IMP Batch Release & Distribution

Eramol provides an integrated approach to batch release and IMP supply, ensuring smooth continuity across the product lifecycle:

UK, EU, and global distribution hubs
Controlled storage: ambient (15–25°C), cold chain (2–8°C), frozen (-20°C, -80°C)
IVRS/IWRS integration for clinical trial management
Local storage depots: Ireland, UK, Australia (Sydney & Melbourne), Austria, Spain, North America, Canada, Brazil
Approved courier network for same-day, direct, next-day, and cold-chain shipments
Validated transport shippers and full IMP return/destruction management
24/7 emergency logistics support

Our UK and Ireland QPs work within a common quality system, ensuring seamless batch release and IMP transition across EU and UK boundaries.

Global QP Release Beyond the EU & UK

In addition to EU and UK batch release, Eramol offers QP oversight for third-country GMP declarations, enabling compliant importation and distribution globally.

Post-Brexit, our dual-site UK/Ireland QP structure guarantees hassle-free supply chains for EU and UK clinical trials.

Specialist Regulatory & CMC Support

Eramol QPs provide expert guidance on regulatory strategy, chemistry, manufacturing, and controls (CMC), and dosage form development:

Supply chain assessments and risk mitigation
IMPD creation and review
GxP troubleshooting across manufacturing and distribution
Integration of QPs across UK and Ireland facilities
Direct QP support throughout the project lifecycle
Consultancy for both clinical and commercial products, including small- and large-scale manufacturing

Eramol QPs have led innovative projects, such as the first decentralised manufacturing process for a time-critical ATMP IMP approved by MHRA, demonstrating our high-level expertise in complex regulatory environments.

Partner With Eramol for QP Release & Regulatory Support

Eramol delivers expert QP release services and regulatory guidance to ensure your IMPs meet the highest standards of quality, safety, and compliance. Our integrated approach provides:

Experienced QPs for UK, EU, and global releases
Seamless transition across manufacturing, storage, and distribution
Regulatory oversight and advice for complex trials and products
Full support for audits, inspections, and supply chain assessments

Whether you are planning a first-in-human study or global commercial launch, Eramol provides a trusted, expert-led solution to keep your IMP supply compliant and on schedule.