Analytical Services provides analytical testing and support for drug development from early stage research through commercialization. This includes API and drug product testing, method development and validation, stability testing, physical and chemical characterization, and analytical support for clinical trials. Analytical Services has over 150 analysts and state-of-the-art laboratories and equipment to meet all analytical needs throughout drug development.

1. Analytical Services
Meeting your analytical needs throughout drug development.
> API and Drug Product Testing
> Analytical Support for Clinical Trials
> Comparator Testing
> Physical and Chemical Characterisation
> Method Development and Validation
> ICH Stability Testing
Analytical Services
www.almacgroup.com

2. Commercial Services
Analytical Services
Clinical Technologies
Meeting your analytical needs throughout drug development.
From our state-of-the-art analytical laboratories, our highly skilled analysts deliver comprehensive
analytical solutions to support your drug substance and drug product development programmes, as well
as providing analytical and microbiological testing solutions for clinical and commercial drug product
Clinical Trial Supply
supply. Employing over 150 analysts at one site, we examine your drug substance and drug products
chemical, physical and microbiological properties to support clinical manufacturing, commercial release,
and stand-alone analytical projects.
Analytical Services
Product Testing
> API
Method Development & Validation
> Assay
Analytical Support to Clinical Trial Supplies
> Drug product > Related substances
Almac can provide the necessary on-site analytical support for all your clinical packaging projects and
Pharmaceutical Development
> Clinical trial material > Dissolution
> Comparator > Cleaning verification beyond. Our dedicated analytical chemists provide information rich data on both comparator and
> Stability indicating
innovator material in full compliance with regulatory requirements.
Comparator Testing > Bioanalysis
> Method development and validation
> Comparator dissolution Stability Testing
> Stability API and Drug Product
> Accelerated and long-term
studies at all ICH conditions Capabilities:
Physical Characterisation
> Polymorph screening > Protocol and report preparation > Identification / Absence of active
API Services & Chemical Development
> Intrinsic dissolution > Elucidation of degradation pathways > Characterisation
> Thermal properties > Identification of degradants > Release testing of IMPs
> Particle morphology > Synthesis of degradants > Comparator studies
> Method transfer
Chemical Characterisation > Method development
> Proof of structure > Method verification or validation
> Identification of impurities > Stability testing
> Identification of degradants > Re-assay
> Identification of metabolites
Biomarker Discovery & Development
Our method development team routinely work with challenging drug molecules in order to establish
fit-for-purpose methods utilising cutting edge technology. This enables our customers to benefit from having the
right data, at the right time, to the highest standards. Almac’s highly experienced stability testing group provides
a turn-key service encompassing protocol writing, sample labelling and storage, study management, analytical
testing and report writing. Unique to Almac is the ability to identify, isolate and synthesize degradation products
that may form on storage.

3. www.almacgroup.com
Commercial Services
Comparator Studies
Comparator activities Active and Placebo activities
Clinical Technologies
> Develop and validate analytical methods > Cleaning analytical method verification
> Structure elucidation of organic > Validation / transfer of drug product
impurities analytical methods
> Over-encapsulated comparator stability > Manufacture technical batch of customers’
profile active tablet formulation
Clinical Trial Supply
> Manufacture and release of GMP > Manufacture and release clinical batch of
batches of over-encapsulated comparator customers’ active tablet formulation
> Manufacture and release of placebo tablets
> Manufacture and release of over-encapsulated
active tablets
> ICH stability
Analytical Services
Comparator Products
Pharmaceutical Development
> Penicillin VK > Hydroxychlorquine Sulphate > Formoterol
> Morphine Sulphate ER > Levofloxacin > Aspirin
> Morphine Sulphate IR > Carbamaxepine > Omeprazole
> Oxycodone > Trimethobenzamide > Minocyline
> Simvastatin > Telithromycin > Isosorbide-5-mononitrate
> Pravastatin > Zolpidem Tartrate
> Atorvastatin > Glipizide
> Warfarin Sodium > Budesonide
API Services & Chemical Development
Equipment Capabilities
> HPLC > LC-MSn > NMR > Microscopy
> UPLC > GC-MS > FTIR > Particle Sizing
> Ion Chromatography > MALDI-TOF > UV > DSC
> GC > Polarimetry > TGA
Biomarker Discovery & Development
> GC-HS > DVS
> Dissolution
For European Enquiries: For American Enquiries:
Almac Almac Group Incorporated
Almac House 25 Fretz Road
20 Seagoe Industrial Estate, Souderton, PA 18964
Craigavon, BT63 5QD, United States of America
United Kingdom. T +1 (215) 660 8500
T: +44 (0) 28 3833 2200 E: sciences@almacgroup.com
E: sciences@almacgroup.com
www.almacgroup.com