1. Accelerated Process Integrated Drug Development
Key Benefits:
> Lead candidate to Phase I
Regulatory submission in 12 months
> Realise milestones earlier
> Flexible solutions tailored to your
requirements
> Truly integrated in-house
capabilities, on a single site
> Preclinical safety assessment studies
> Dedicated project management
> Single contract & commercial contact
> Reduce effort spent on auditing,
coordinating and managing
multiple vendors
API Services &
Chemical Development
www.almacgroup.com
2. www.almacgroup.com
Commercial Services
Would you like to save 12 months
in early clinical development?
Clinical Technologies
offers a complete set of solutions aimed at accelerating entry into early clinical
development. is a lean, efficient, integrated solution from selection of pre-clinical
candidate to Phase I regulatory submission.
Clinical Trial Supply
Almac, in collaboration with a selection of preferred CROs, provides world class talent delivering a unique
drug development package leading to completion of Phase I regulatory submission in under 12 months.
Analytical Services
offers:
Pharmaceutical Development
API (small molecule or peptide) Pre-clinical Safety Assessment
> Toxicology Supply > Genetic Toxicology
> GMP Supply > Toxicology
> Radiolabelling > Safety Pharmacology
> Solid State Characterisation > Bioanalysis
(polymorph & co-crystal screen) > Metabolism
Analytical Support Regulatory Support
> Analytical Method Development > CMC
> Validation > Regulatory Documentation (IMPD/IB)
API Services & Chemical Development
> API & Drug Product Stability > CTA/IND submission
Studies
Pharmacodynamic Biomarkers
Drug Product
> Pre-formulation
> Formulation Development
> Manufacture, Packaging, Labelling
& Release
Biomarker Discovery & Development
For European Enquiries: For American Enquiries:
Almac Almac Group Incorporated
Sciences 25 Fretz Road
Almac House Souderton, PA 18964
20 Seagoe Industrial Estate, United States of America
Craigavon, BT63 5QD, T +1 (215) 660 8500
United Kingdom. E: sciences@almacgroup.com
T: +44 (0) 28 3833 2200
E: sciences@almacgroup.com
www.almacgroup.com