Manufacturing & Pharmacy Services

Reduce drug development timelines and improve clinical outcomes

ICON’s Manufacturing & Pharmacy Services offer a seamless, end-to-end approach to formulation development and optimisation for both small molecules and biologics.

Our integrated capabilities span the full development lifecycle, including small-batch formulation screening and optimisation, analytical method development and validation, stability storage and testing, mock dosing and release testing, as well as packaging, labelling, and distribution. We also provide specialist expertise in complex areas such as oncology therapies and carbon-14–labelled products.

With GMP-compliant manufacturing sites equipped with on-site GMP Quality Control (QC) laboratories, we streamline formulation development and stability/compatibility studies alongside QC processes. This enables faster early clinical manufacturing, supporting high-risk and radiolabelled investigational medicinal products (IMP) for early phase studies in both healthy volunteers and patients across Europe and the U.S.

ICON's small batch early clinical manufacturing offers advantages over the traditional large-scale production in several ways. It reduces waste through right-sized production, uses fewer raw materials and energy consumption, and reduces transport emissions due to the close proximity to clinical trial sites.

Let ICON help you accelerate drug development, reduce risk, and bring your therapies to patients.

Delivering measurable benefits to your trial

Faster development timelines

Custom formulations designed to meet clinical objectives, reducing trial duration and accelerating progress to the next phase.
Real-time dose flexibility allows for quick trial adjustments, reducing delays between cohorts.

Cost savings & efficiency gains

Reduced trial iterations by identifying the most effective formulation upfront, minimising wasted resources.
Integrated CMC & regulatory services streamline distribution and eliminate outsourcing delays.

More sustainable approach

Reduced waste through right-sized production of small batches for early phase trials , minimising the risk of drug expiration or disposal due to excess.
Lower resource consumption due to smaller scale manufacturing, requiring less active pharmaceutical ingredients (APIs), solvents, and excipients.
Localised production which reduces transport emissions and supply chain complexity

Improved clinical outcomes

Optimised formulations enhance PK profiles, improving patient response and increasing the likelihood of regulatory approval.
Rapid turnaround of clinical data enables real-time decision-making, accelerating commercialisation and reducing costs.

Solutions:

Rapid & efficient formulation development

Leverage our extensive formulation expertise to accelerate your product’s journey from concept to reality. Our efficient screening process ensures faster, more effective formulation development.

Formulation optimisation for better clinical outcomes

Through a strategic design window of four fixed compositions, we pinpoint the formulation that delivers the optimal pharmacokinetic (PK) results—ensuring superior efficacy and performance. This approach helps to streamline the trial process and reduce trial iterations, ultimately saving time and costs.

Cutting-edge analytical method development validation

Our GMP laboratories provide analytical testing support for active pharmaceutical ingredients (API), intermediates, raw materials, in-process samples and finished products for all dosage forms of small and large molecules across phases of drug development. We support a variety of methodologies ranging from phase appropriate analytical method development and validation to transfer of existing assays.

Stability storage and testing under controlled conditions

We conduct ICH-compliant stability assessments under accelerated, frozen, refrigerated, and controlled room temperature conditions to ensure product integrity.

Compatibility assessment

We evaluate drug product compatibility with dose containers (e.g., syringes, IV bags) and administration ancillaries (e.g., cannulas, valves) to minimize risks and ensure smooth clinical use.

Flexible small-scale manufacturing & release testing

From tablets and capsules to sterile formulations and radiolabelled drugs, we provide real-time dose flexibility, allowing you to quickly adapt formulations without delays.

Regulatory-compliant packaging & labelling

We offer primary and secondary packaging across all clinical phases, with multilingual labeling that meets global regulatory requirements.

Global depot & distribution for faster study start-up

Our worldwide distribution network ensures your drug reaches any clinical site or hospital efficiently— minimising delays and keeping trials on schedule.

Qualified Person (QP) & regulatory support

Our QP-certified experts facilitate regulatory approvals, audits, and rapid clinical trial release of the IMP, ensuring smooth progression through development stages. ICON’s Qualified Persons support QP declarations, audits, and IMP release under the MIA (Manufacturing Import Authorisation.) Rapid batch manufacturing and stability studies enable quick formulation evaluation, with parallel execution when needed.

CMC services (manufacturing and regulatory) for high-risk and radiolabelled IMPs

We specialise in CMC services, ensuring expert handling of complex products, including radiosynthesis, drug development, and manufacturing for small patient groups.