Bateman Quality Associates Ltd
Bateman Quality Associates Ltd (BQAL) offers a Quality Assurance consultancy and interim management service to the Pharmaceutical Industry and Fertility Clinics. Our aim is to assist companies to improve efficiency, regulatory compliance and profitability of their operational activities.
Our Pharmaceutical expertise covers most GCP, GMP and GDP activities and we have eligibility to be a Qualified Person for IMPs. We understand the process for API selection for clinical development programs, the subsequent small scale API synthesis for use in toxicological studies and IMP development for clinical trials. 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 steriles. We have experience of site and plant specific audit by European, US and Asian regulatory bodies.
Our proven expertise in quality audit and risk assessment includes:
- Transfer of GxP activities across international boundaries
- Development, maintenance and continuous improvement of quality management systems
- Management of in-house and third party manufacturing quality assurance groups
- Hosting successful regulatory authority inspections (FDA and MHRA) in support of manufacturing and marketing authorisations
- Management and auditing of supply chain (goods inwards to distribution of product)
- Quality management of validation systems
- Design and commissioning of manufacturing and laboratory facilities
- Analysis of starting materials and products
Fertility Clinics throughout the UK must demonstrate compliance to increasingly rigorous licensing / registration requirements set by the Human Fertilisation and Embryology Authority (HFEA) and, where applicable, the Care Quality Commission (CQC). BQAL has current expertise in the development of quality management systems and corresponding audit of clinics and their product / service providers to demonstrate compliance. This expertise is proven by successful outcomes to a variety of inspection (e.g. new clinic, relicensing, interim and unannounced inspections) by both regulators and ISO9001 assessors at a number of clinics.
Availability for work
We offer our services throughout most regions of the world.
Key Areas of Expertise
GCP, GMP, GDP, GcLP, cGMP, ISO9001, ISO17025, HFEA Code of Practice
For more information please contact:
|Dr Tim Bateman, BSc, MSc, C.Chem. FRSC||Mrs Karen Bateman C.Chem. FRSC
|Telephone: +44 (0)1487 840458
||Telephone: +44 (0)1487 840458|
|Mobile: +44 (0)7765 935665||Mobile: +44 (0)7495 768510|
|E-mail: firstname.lastname@example.org||E-mail: email@example.com|