Bateman Quality Associates Ltd (BQAL) offers a Quality Assurance consultancy and interim management service to the Pharmaceutical Industry and Fertility Healthcare Clinics. Our aim is to assist companies to improve efficiency, regulatory compliance and profitability of their operational activities.
Experience gained in pharmaceutical and chemical manufacturing environments covers simple and complex processes for API manufacture (small molecules, fermentation products, biologics and vaccines) in small and large batch sizes and a wide range of finished product dosage formats including sterile products (terminal sterilisation and aseptic filling). We have experience of site and plant specific audit by European, US and Asian regulatory bodies.
Fertility Clinics must demonstrate compliance to increasingly rigorous regulatory requirements such as those set by the Human Fertilisation and Embryology Authority (HFEA). BQAL has expertise in the development of quality management systems, audit of clinics and their product / service providers to demonstrate compliance with applicable regulatory requirements and / or licence requirements. This expertise is proven by successful outcomes to a variety of inspection by regulators and ISO9001 assessors at a number of clinics (e.g. new clinic, relicensing, interim and unannounced inspections).
Tim has in depth knowledge of API manufacture, primary and secondary product manufacturing (all dosage formats). He also has first hand experience of the drug development functions, including the manufacture and control of investigational medicinal products for use in clinical trials.
Tim is experienced in regulatory requirements within Europe, USA, Asia & Africa and has a wide range of skills including: Development, maintenance and continuous improvement of quality management systems; Management of quality assurance groups; Hosting successful regulatory authority inspections (FDA and MHRA) in support of manufacturing & marketing authorisations; Management and auditing of pharmaceutical supply chain; Quality management of validation systems; Commissioning of manufacturing and laboratory facilities; Analysis of starting materials and products; Troubleshooting.
Karen has first hand knowledge of the Quality Assurance and audit requirements relating to API selection for clinical development programmes; the subsequent small scale API synthesis for use in toxicological studies and IMP development for clinical trials. Experience gained in chemical manufacturing and pharmaceutical environments covers simple and complex processes for API manufacture and a wide range of finished product dosage formats.
Karen understands the increasingly rigorous requirements Fertility Healthcare Clinics must meet to enable them to operate within local regulatory requirements. Karen has recent experience that has provided her with expertise in the development of quality management systems and corresponding audit of clinics and their product / service providers to demonstrate compliance to these requirements both in the UK and overseas. This expertise is proven by successful outcomes at a number of clinics to initial, relicensing, interim and unannounced inspections.
