About Custom pharma services
Custom Pharma Services: Your Trusted Partner in Pharmaceutical CDMO
Custom Pharma Services is a fully-licensed pharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in providing comprehensive services to the pharmaceutical industry. With our state-of-the-art facilities, cutting-edge technology, and highly skilled team of experts, we are capable of taking your compound from clinical to commercial.
At Custom Pharma Services, we understand the importance of quality and compliance in the pharmaceutical industry. That's why we adhere to strict regulatory guidelines set by global regulatory authorities such as FDA, EMA, MHRA, TGA and ANVISA. Our commitment to quality is reflected in our ISO 9001:2015 certification for Quality Management Systems.
Our services include drug development, formulation development, analytical testing services (including method development/validation), stability studies (ICH/real-time), clinical trial material manufacturing/packaging/labelling/distribution/storage/returns/destruction/disposal), commercial manufacturing/packaging/labelling/distribution/storage/returns/destruction/disposal), supply chain management/logistics support and regulatory affairs support.
Drug Development
Our drug development team has extensive experience in developing small molecules as well as biologics including monoclonal antibodies (mAbs) and recombinant proteins. We offer a range of drug discovery services including hit-to-lead optimization studies using high-throughput screening techniques such as SPR/Biacore/LigandTracer/NanoDSF/MST/ForteBio Octet/QCM-D etc., medicinal chemistry optimization studies using structure-based design or fragment-based design approaches with computational modeling tools like Schrodinger Suite/Gold/Cresset/Tripos/Sybyl/MOE etc., preclinical pharmacology/toxicology studies using animal models like mice/rats/guinea pigs/rabbits/dogs/non-human primates etc., IND-enabling toxicology/pharmacokinetics/pharmacodynamics/bioavailability/bioequivalence studies, and clinical trial design/execution/management.
Formulation Development
Our formulation development team has expertise in developing a wide range of dosage forms including tablets, capsules, softgels, liquids (solutions/suspensions/emulsions), semi-solids (creams/ointments/gels), powders (lyophilized/powder for injection/inhalation) and transdermal patches. We offer a range of formulation development services including preformulation studies to determine the physicochemical properties of your compound such as solubility/stability/permeability/pKa/logP etc., formulation screening studies to identify the optimal dosage form based on your target product profile (TPP) and critical quality attributes (CQAs), process optimization studies to scale up your formulation from lab-scale to pilot-scale to commercial-scale using QbD principles with Design of Experiments (DoE) approach.
Analytical Testing Services
Our analytical testing team has expertise in developing and validating methods for a wide range of analytical techniques including HPLC/UPLC/GC/LCMS/ICP-MS/NMR/XRD/DSC/TGA/DMA etc. We offer a range of analytical testing services including method development/validation/transfers, release/stability testing for drug substance/drug product/excipients/raw materials/packaging materials/environmental monitoring/water system validation/cleaning validation/microbiological testing/toxicology/pathology/bioanalysis etc.
Stability Studies
Our stability study team has expertise in conducting ICH-compliant stability studies as well as real-time stability studies under controlled conditions. We offer a range of stability study services including accelerated/degradation/stress/retest/recovery/shelf-life/dose uniformity/vaccine potency/vaccine adjuvant compatibility tests.
Clinical Trial Material Manufacturing/Packaging/Labelling/Distribution/Storage/Returns/Destruction/Disposal
Our clinical trial material team has expertise in manufacturing, packaging, labelling, distributing, storing, returning and disposing of clinical trial materials (CTMs) for Phase I-IV clinical trials. We offer a range of CTM services including GMP-compliant manufacturing/packaging/labelling/distribution/storage/returns/destruction/disposal using QbD principles with DoE approach.
Commercial Manufacturing/Packaging/Labelling/Distribution/Storage/Returns/Destruction/Disposal
Our commercial manufacturing team has expertise in manufacturing, packaging, labelling, distributing, storing and disposing of commercial products for global markets. We offer a range of commercial services including GMP-compliant manufacturing/packaging/labelling/distribution/storage/returns/destruction/disposal using QbD principles with DoE approach.
Supply Chain Management/Logistics Support
Our supply chain management/logistics support team has expertise in managing the entire supply chain from raw material procurement to finished product delivery to customers. We offer a range of supply chain/logistics services including vendor qualification/supplier management/inventory management/planning/scheduling/order processing/shipping/tracking/customs clearance/import/export documentation etc.
Regulatory Affairs Support
Our regulatory affairs support team has expertise in preparing regulatory submissions for global markets such as IND/NDA/ANDA/Biologics License Application (BLA)/Marketing Authorization Application (MAA)/Common Technical Document (CTD)/Electronic Common Technical Document (eCTD). We offer a range of regulatory affairs services including gap analysis/regulatory strategy development/preparation/submission/review/response to deficiency letters/post-approval maintenance activities etc.
Custom Pharma Services: Your Partner from Clinical to Commercial
At Custom Pharma Services we are committed to providing our clients with high-quality pharmaceutical CDMO services that meet their unique needs. Our state-of-the-art facilities and highly skilled team ensure that your compound is taken from clinical to commercial successfully. Contact us today to learn more about how we can help you achieve your goals. CustomCan!
custompharma.co.uk