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Bioprogress BPRG - Serious Investors Only (Moderated)
Hambi - Thu, 21 Dec 06 :
Inghu: I also think that the development services offered by Inxy are very important given that at present bprg is stretched across a large number of technologies and developments:
"...Our manufacturing facilities enable the supply of quantities needed for even the largest clinical trial.
Assistance can be provided for new chemical entities, new products or line extensions...
Analytical Development & Validation
Our Development Group works closely with internal and external customers to provide method development and validation services that support pre-formulation and stability testing. The group is equipped with state-of-the-art analytical instrumentation including automated HPLCs, Gas Liquid Chromatography, Malvern Particle Sizer and Anderson Cascade Impactors. Generated methods and reports are used to support customers’ worldwide regulatory submissions.
Stability Services
Clients have the ability to contract a full turnkey operation, which includes formulation and analytical development, through production scale process validation and batch stability, to license submission support and production for market at our Astmoor manufacturing site. Alternatively, customers can contract any combination of the individual component services with our Development Group.
Integrated Project Management
Our Development Group also provides extensive time point testing, which enables the guidance of customers to the appropriate stability protocol for a particular type of dosage form and targeted geographic markets. Large, walk-in stability chambers, all operating within regulatory guidelines, offer the flexible capacity to meet world- wide market requirements. Stability services will be expanded as customer demand for this type of development service grows. "
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