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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
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

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Rapidd™

  • 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