Analytical Method Development & Stability Studies

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Analytical method development & stability studies

Evolving our Analytics offer

Eramol is constantly evolving its capabilities and areas of expertise.

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To this end, we offer Analytical Method Development services that bring into play new chemical entities, as well as the refinement of existing analytical methods. These include:

  • ICH analytical method validation and verification services that cover a wide range of pharmaceuticals and APIs, including all documentation and reporting.
  • Analytical Method Transfer via comparative testing, for both co-validation or full re-validation.
  • Full ICH stability options are available upon request. These include accelerated, real-time and transportation stability studies.
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Our Other Services

Formulation Development

Eramol offers clinical formulation development and manufacturing services to enable you to develop your product and speed up your time to market. We’ll work with you to develop an effective formulation – either in solid tablet, capsule or liquid form – giving you optimal clinical outcomes that can support your product across all clinical trial phases.

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, integrating advanced isolator technology, closed-system processing, moist heat terminal sterilisation, and a full end-to-end clinical supply chain — ensuring your sterile injectable reaches 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.

Clinical Packaging

We recognise that the challenge of acquiring adequate placebos is considerable, whether it be matching a placebo or making an active comparator.

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.

EU & UK QP Release

QP Release is a critical stage in clinical trials: it is the process whereby Qualified Persons (QPs) ensure that a batch of investigative medicinal products (IMPs) that has been manufactured are of a high enough quality that they can be released for use in clinical trials.

Reliable. Proven. Safe. Effective.

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Reliable. Proven. Safe. Effective.

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Email

enquiry.uk@eramol.com

Phone

+44 (0) 1293 368080