Clinical Research & Development Factsheet

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Clinical Research & Development Factsheet

  1. 1. Bilcare Global Clinical Supplies, Americas Tel 610 935 4300 300 Kimberton Road Fax 610 935 4301 Phoenixville, PA 19460-2123 Clinical Research & Development Analytical Services & Formulation Development Technical Services Bilcare provides innovative solutions for all of your + Provide experienced professionals to Our quality process demands that all R&D processing needs. Our dedicated personnel provide troubleshoot commercial products documentation is reviewed and approved by our technical support during each phase of your + Evaluate new raw materials in existing quality team. product’s development and manufacturing. GMP products Controlled Substance Management qualified scientists oversee comprehensive + Transfer of products from research to Bilcare is registered with the DEA as a development and testing of your materials. We take production facilities Manufacturer, Distributor, Exporter, Importer extra steps to ensure that your products comply with + Assess current products and recommend and Analytical Laboratory of Controlled international regulatory standards. improvements to modernize existing Substances. manufacturing processes Formulation Development The Bilcare Team of experienced formulation Analytical Research specialists is always ready to provide you with Bilcare provides the best solutions for every high-speed throughput of innovative formula- stage of your product development. Our tions for clinical trials. Our broad range of for- comprehensive package of analytical services mulation development services includes: for the drug, as well as the packaging Pre-Formulation materials, components and systems include: + Physical properties + Accelerated drug stressing + Product characterization + Chromatographic impurity profiling + Chemical compatibility and reactivity to + Cleaning validations for packaging substrates manufacturing equipment + Accelerated degradation + Dissolution profile testing + Excipient compatibility studies + Extractable studies for parenteral products Formulation Development + Competitor analysis for unbiased + Clinical supplies manufacturing de-formulation + Blending and encapsulation + Hygroscopicity studies + Over-encapsulation and blinding + Method development and validation for + Phase I-IV development and reformulations all phases and all components in + Placebo manufacturing/comparator development of drug substance, non- supplies compendial excipients and drug product + Develop both ethical and over-the-counter + Process development support products: tablets (normal and controlled + Release testing release), powders, liquids, suspensions, + Reference standard qualification testing emulsions, creams and ointments, lotions + Stability study protocol design + Develop line extensions in the above dosage (ICH and custom) forms + Mapped environmental chambers including 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, 25°C/40% RH, 40°C/25% RH, 5°C, and photo stability Service and Quality Beyond Compliance. www.BilcareGCS.com

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