QP Support

QP Support

Expert advice when, and where, it counts

Eramol QPs have a wide range of knowledge and experience to provide expert regulatory and CMC (chemistry, manufacturing and controls) advice to clients planning clinical trials.

Our QPs can provide specialist advice on a wide range of dosage forms, as well as practical formulation & manufacturing advice for small- and large-scale production.

Eramol’s QPs can perform UK and EU batch release for clinical and commercial drug products, as well as for other parts of the world.

As testament to our expertise, Eramol QPs were instrumental in developing and implementing a de-centralised mmanufacturing pprocess for a time-critical and ground-breaking Advanced Therapy Medical Product (ATMP) IMP, which was the first of its type to receive MHRA CTA approval.

Eramol’s support offer includes:

  • Supply chain assessments
  • QP Audits & QP 3rd country Declarations
  • QP integration across Eramol’s UK and Ireland facilities
  • Direct QP contact throughout the Project lifecycle
  • IMPD creation
  • GxP troubleshooting

Call upon our Consultancy Services

Our QPs are on hand to provide expert consultancy advice to all clients. The QPs are always happy to discuss your clinical or commercial requirements via free consultations. Contact Us.

Our Other Services

Sterile Manufacturing

Eramol delivers a purpose-built, EU GMP Annex 1–compliant sterile manufacturing service dedicated to Phase I and Phase II clinical trial supply. Our facility is designed for agility, reliability, and regulatory strength by integrating advanced isolator technology, closed-system processing, moist heat terminal sterilisation and a full end-to-end clinical supply chain — ensuring your sterile injectable, cartridges and pre filled syringes reach patients safely, on time and in full regulatory compliance.

Non Sterile Manufacturing

GMP Production of Tablets, Capsules & Oral Liquids for Phase I–III and Commercial Supply Eramol delivers end-to-end non-sterile manufacturing built on a foundation of quality, regulatory expertise, and Qualified Person (QP) leadership. Our Sevenoaks GMP facility, commissioned in November 2021 and operational since August 2022, supports the full product lifecycle—from early-phase clinical development right through to commercial supply.

Labelling Solutions

Our versatile and extensive labelling solutions have been designed to offer flexibility, economy of scale and to meet the demands of last-minute requirements.

Reliable. Proven. Safe. Effective.

Reliable. Proven. Safe. Effective.

Speak With Us

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