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Farmalyse

Laboratory Contract Services

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Farmalyse

Farmalyse is a contract service provider for the pharmaceutical industry, hospitals and the medical device industry offering a full range of laboratory investigation services, quality control testing, analytical method development-validation and comprehensive and customised international services which focus on import, release and supply chain management.

Farmalyse is accredited with relevant good manufacturing practice (GMP), control laboratory practice (GcLP), ISO 9002 and ISO 14385 certifications. Our services are also calibrated to the OECD-GLP and ICH guidelines.

With over 12 years of experience in the industry, we serve our clients with a strong emphasis on reliability and speed. Offering flexibility to customers’ requirements on reliable throughput times and maintaining a strong emphasis on quality assurance, we provide a customised tailor-made package of services sensitive to the requirements and specifications of our sponsors.

Our experience and expertise, together with that of our global clients and our partner network, assure the best of reliability, speed and quality in all Farmalyse services.

Quality control testing and laboratory investigations

One of the core competencies of Farmalyse is to provide specific solutions for clients to apply to their business model and outsourcing needs. With over 90% retention of sponsors, we take pride in offering them the best of our services and continually grow with them to adapt to their requirements and needs.

Farmalyse provides services in four broad domains:

  • Quality control testing (raw materials to finished products)
  • Laboratory investigations
  • Qualified person (QP), regulatory (RA) and quality assurance (QA) services
  • International services

Laboratory contract services

We cater to more than 100 clients from across the world, including the UK, mainland Europe, the Middle East, India and the US in a variety of industry sectors and sub-sectors, such as generics, medical devices, proprietary products, raw materials, hospitals and cosmetics.

Our major clients include Novartis, Astellas, Ranbaxy Laboratories, Actavis, Abbott, and Schering-Plough among others.

 

Farmalyse B.V.
Pieter Lieftinckweg 2
1505-HX Zaandam
The Netherlands

Tel: +31 75 612 3666
Fax: +31 75 612 4077
info@farmalyse.nl
www.farmalyse.nl

European Healthcare Services

European Healthcare Services (EHS), a joint consortium managed and operated by Farmalyse, NYK Logistics and Bactimm, is your pharmaceutical gateway into Europe.

With in-house experience in laboratory services, quality control and product release, our association with NYK Logistics enables us to jointly offer a consolidated pan-European supply chain solution which manages all aspects of European operations. In essence, it is your gateway into Europe for imported finished formulations, medical devices or raw materials. Offering regulatory support, laboratory…

Laboratory Investigations

Farmalyse carries out method development and validation studies according to international guidelines, using standard validation packages in conformity with ICH guidance.

A validation project comprises a study plan, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report. Validation studies are performed by dedicated staff with special training on study handling, in accordance with international guidelines, such as PhEur, USP and ICH. Standard throughput times are between…

Qualified Person, Regulatory and Quality Assurance Services

Farmalyse offers qualified person (QP) and regulatory services from a pool of two in-house QPs and two external QPs based on the requirements and specifications of our sponsor.

Quality assurance (QA) services include: Liaising with relevant EU authorities for submissions and evaluations Preparation of CTD Registrations of dossiers CoS Independent site-audits DMF and document writing Protocol preparation Consultancy and related services Please contact us for a full list of our QA and consultancy services.

Quality Control Testing

Farmalyse performs pharmacopoeial and non-pharmacopoeial tests routinely on a large scale basis for pharmaceutical products and medical devices in compliance with GMP-GCLP.

All our tests are based on the concept of a one-stop-shop. We combine chemical and microbial product knowledge with quality control testing, method development and validation studies for finished formulations, active pharmaceutical ingredients (APIs), excipients and medical devices. Through our state-of-the-art laboratories we offer a complete range of services including chromatography facilities (HPLC, UPLC, GC,…
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