Quality Assistance

Quality Assistance provides (bio)pharmaceutical companies with a comprehensive range of analytical and bioanalytical services compliant with the highest quality standards.

Participated at Bio/PharMOS-Bio/PharDOS 2006

Objective : Quality Assistance would like to meet potential partners who, having discovered promising molecules or products via their research programmes, need to outsource (bio)analytical work. We can provide the (bio)analytical data required to help you through the registration procedure for both Europe and the US.

About Quality Assistance : A leading European CRO with over 20 years' experience in providing pharmaceutical and biopharmaceutical sectors with regulatory and analytical support for the development and optimisation of their products.

• 75 highly-qualified employees
• 3,200 m² of laboratories, including stability storage chambers, BL2 and BL3 facilities
• Customers : big pharma groups (8 of top 10), biotech companies
• FDA inspected (July 2003, no 483s issued)
• Recognised by the EMEA ( European Medicinal Evaluation Agency )
• Certified GLP compliant
• ISO 17025 accredited

Examples of what we do :

• API characterisation.
• Development of analytical techniques (for assays, purity evaluation, microbial contamination, assays in biological matrices for pre-clinical/clinical pharmacokinetics, etc.).
• Validation according to ICH, EMEA, FDA guidelines; Washington conference for bioanalysis, etc.
• Stability studies : long-term, accelerated, photostability, in-use, cycling (e.g. freeze-thaw).
• Cleaning validation, including protocol writing and analyses.
• Management of technical aspects and quality assurance of pre-clinical and clinical phases I and II, including administration in a GLP veterinary centre or in appropriate human clinical centres. The bioanalyses are done in our laboratory.
• Assistance to non-EU companies with regulatory and technical approaches to the European market, and importation and release of their marketed products.

Interests

• branded prescription products
• clinical trial materials (CTS or CTM)
• generic pharmaceutical products
• OTCs or nutraceutical products
• antibiotics or cytotoxic products
• drug delivery systems or technologie
• contract biologics manufacturing
• biopharmaceuticals
• vaccines or immunotherapeutics
• monoclonal or polyclonal antibodies
• microbial production technologies
• yeast or fungal production technologies
• mammalian cell culture production
• plant-based production technologies
• insect cell based production
• transgenic production technologies
• batch and fed-batch production
• consulting services for outsourcing
• bio-process development
• viral expression systems
• continuous fermentation system
• downstream processing of biologics
• scale-up from pilot to commercial volume
• sterile (aseptic) fill & finish processing
• lyophilisation (freeze-drying) services
• process validation, safety and testing

Activities

• Stability testing and storage
• antibiotics or cytotoxic product
• contract development services
• pharmaceutical development services (PDS)
• validation and compliance
• quality control (QC) or QA
• analytical testing and batch release
• metabolism or bioequivalence services
• biopharmaceuticals
• vaccines or immunotherapeutics
• process validation, safety and testing