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