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Download Brochure (4.9mb) - Almac

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Drug Development<br />

Let <strong>Almac</strong> Give You the Advantage<br />

Biomarker Discovery & Development<br />

API Services & Chemical Development<br />

Pharmaceutical Development<br />

Analytical Services<br />

Clinical Trial Supply<br />

Clinical Technologies<br />

Commercial Services


Biomarker Discovery & Development API Services & Chemical Development Pharmaceutical Development Analytical Services Clinical Trial Supply Clinical Technologies Commercial Services<br />

For a superb service in drug<br />

development...trust <strong>Almac</strong>.<br />

<strong>Almac</strong> has over 30 years experience and can offer one contract for our extensive<br />

range of services. This, along with our streamlined management process, innovative<br />

approach and proven quality record reduces risk and time to market, making <strong>Almac</strong><br />

the major global player you’ve been looking for.<br />

Biomarker Discovery & Development<br />

<strong>Almac</strong> provides a wide range of biomarker solutions.<br />

These range from pre-clinical biomarker discovery,<br />

through to biomarker trial management, full<br />

companion diagnostic development and clinical test<br />

delivery from our CLIA laboratory. We have a portfolio<br />

of proprietary discovery arrays and extensive<br />

experience and expertise working with formalin fixed<br />

paraffin embedded (FFPE) tissue.<br />

API Services & Chemical Development<br />

<strong>Almac</strong> provides services for all stages of drug<br />

development for small molecules, potent and cytotoxic<br />

compounds, and peptides. Our services include API<br />

supply, drug product development, stable and<br />

radiolabelling, solid state services and biocatalysis.<br />

We also offer rapidd, a lean, efficient, integrated<br />

package from selection of pre-clinical candidate<br />

to Phase I regulatory submission.<br />

Pharmaceutical Development<br />

Our team of highly skilled scientists can develop your<br />

clinical candidate into an optimum formulation, and<br />

manufacture drug product for all phases of clinical trial<br />

supply (Phase 0 – IV). With bespoke, in-house<br />

engineered containment solutions, we can develop<br />

and manufacture batches of solid, oral dose drug<br />

product containing potent API to an Operator<br />

Exposure Level (OEL) of 0.03 μg/m 3 .<br />

Analytical Services<br />

Our analytical team delivers comprehensive<br />

solutions supporting drug substance (API) and drug<br />

product development programmes including CMC<br />

regulatory filings. Additionally, we provide analytical<br />

and microbiological testing solutions for clinical and<br />

commercial drug product supply.<br />

Clinical Trial Supply<br />

<strong>Almac</strong> has over 20 years experience in clinical<br />

supplies and have successfully packaged, distributed<br />

and delivered supplies for thousands of clinical<br />

protocols. We work with small and large<br />

organisations alike, providing consulting services<br />

such as Supply Chain Management and Qualified<br />

Person release that enhance and supplement the<br />

global clinical supply chain, alongside our core<br />

manufacturing, packaging and distribution activities.<br />

Clinical Technologies<br />

<strong>Almac</strong> has been a leader in providing Interactive Voice<br />

and Web Response technologies since 1995. Through<br />

our industry-leading IXRS ® 2.0 integrated IVR / IWR<br />

technology, we offer flexible solutions for patient<br />

enrolment, screening, randomisation, drug<br />

assignment, inventory management, patient<br />

compliance, electronic Patient-Reported Outcomes,<br />

and adaptive trials. Our experienced teams help<br />

clients streamline R&D, maximise site workflows and<br />

improve overall trial management.<br />

Commercial Services<br />

Ensuring a simple technology transfer process, we offer<br />

integrated commercial services for all drug products<br />

from API supply, manufacturing, testing and packaging<br />

to end-user distribution. Specialising in the<br />

manufacture and primary packaging of solid oral dosage<br />

forms and with a wide range of packaging technologies<br />

we also provide customised secondary labelling and<br />

packaging for biopharmaceutical products. Integrating<br />

EU import testing, packaging, QP release and<br />

distribution, we can assist non-European companies<br />

launch orphan drug or niche products into the<br />

European marketplace.


Biomarker Discovery & Development API Services & Chemical Development Pharmaceutical Development Analytical Services Clinical Trial Supply Clinical Technologies Commercial Services<br />

For European Enquiries:<br />

20 Seagoe Industrial Estate,<br />

Craigavon, BT63 5QD,<br />

United Kingdom.<br />

T +44 (0)28 3833 2200<br />

E info@almacgroup.com<br />

For American Enquiries:<br />

25 Fretz Road<br />

Souderton PA18964<br />

United States of America<br />

T +1 (215) 660 8500<br />

E info@almacgroup.com<br />

ADVANTAGE ALMAC<br />

How can the <strong>Almac</strong> Advantage help you in<br />

drug development?<br />

We offer one contract for all our services providing<br />

security and confidence whilst lifting the burden and risk<br />

of managing multiple vendors. Our streamlined project<br />

management resource enables efficient progress through<br />

drug development, thereby reducing time to market whilst<br />

ensuring scientific continuity.<br />

Over 95% of our business is repeat – evidence of our<br />

commitment to exceed customer expectations. We<br />

continually invest in the long-term development of all<br />

our employees enabling us to maintain our outstanding<br />

quality record.<br />

<strong>Almac</strong>, a privately owned company, with facilities in the UK<br />

and US, has seen over 30 years of continual growth and<br />

partners with over 600 companies worldwide, including<br />

all the market leaders. Our unrivalled range of services,<br />

innovative approach and proven quality record makes us<br />

a major player in drug development both now and for<br />

generations to come.<br />

Unrivalled range of services<br />

Reduce time & mitigate risk<br />

Truly innovative<br />

95% repeat business<br />

Over 30 years experience & growing<br />

Committed & experienced team<br />

almacgroup.com

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