Medical Device , Medicines , Microbiology , Pharmaceuticals Import & Export - Farmalyse BV

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Farmalyse BV - Contract Research and Services - Products/Services

	Ongoing performance control of staff and management according to ISO 9001:2000;
	Routine Microbial Quality Control accredited by the Dutch Health Authorities according to GMP-GCLP (our EU GMP license numbers are 101037 and 101347);
	Frequent participation in internal and external proficiency testing;
	Study specific validations can be executed according to OECD-GLP guidelines.

All tests are performed in dedicated clean rooms suitable for their intended purpose;

Bactimm is preferred supplier for Isotron Netherlands with reference to irradiation validation studies of Medical Devices;

Following tests are performed on large scale routine base:

	Bioburden, Sterility, Tests for Bacterial Endotoxins (LAL), total viable count, total spore forming bacteria;
	Tests for specified micro-organisms;
	Antiseptic and disinfectant activity testing;
	Challenge tests (Preservative Efficacy Test);
	Biological assay of antibiotics.

All tests are performed using validated equipment suitable for their intended purpose;

Farmalyse has extensive experience with many formulations – including non-standardised formulations;

All tests are based on E.P., USP and ICH-guidelines;

Following tests are performed on large scale routine base:

	Assay of active ingredients via HPLC, UV, GC, titration (complexometric, potentiometric as well as indicator based);
	Assay of Organic Volatile impurities via head-space GC;
$Particle size analysis by means of laser diffraction;$	Particle size analysis by means of laser diffraction;
	Dissolution tests of solid oral dosage forms;
	Stability testing performed in temperature/humidity controlled, calibrated and monitored cabinets.

	Because of the vast amount of Application Files designed by Farmalyse and Bactimm the last 10 years, method development is the key-service we are able to provide within an adequate time frame;
	Method development and subsequent reports are implemented based on GLP making use of a clear and structured throughput of projects as such;
	Next to analytical services, we are your key-partner with reference to setting up Application Files and Expert Reports.

	Non-routine pharmaceutical analysis are defined as projects within the company;
	Projects are managed by non-routine staff in order to facilitate throughput meeting time limits as agreed upon in a detailed quotation;
	Project Reports are specifically designed for Regulatory Purpose.

Farmalyse BV - Medical Device

Farmalyse BV - Medicines

Phone No : +44 208 445 5303 Fax No : +44 845 280 3373
E-mail : info@pharmaceutical-industry.info