ABOUT US
Supporting Global Pharmaceutical Supply Chains
Cobalt Pharma Consultancy Ltd provides a wide range of support services to the pharmaceutical manufacturing industry worldwide. We provide consultants with real-world experience of a wide range of dosage forms and product classifications. We provide support services to suit specific business needs, and the needs of the Global Regulatory Environment. We specialise in supporting Emerging Markets and Global Supply Chain Activities.
THE TEAM
SHEILA SHADBOLT
Company Director and Principal Consultant
Sheila is an experienced QA professional with over 15 years’ experience in the pharmaceutical manufacturing environment in technical, quality and managerial roles within both QA and QC. Nominated on UK manufacturing licences as a Qualified Person and a Responsible Person, and has extensive experience of both human and veterinary products within parenteral, non-sterile liquid, Vaccines & Biological product manufacture.
Strategic Leadership of Quality organisations, both QA and QC testing and GMP laboratory operations. Practical experience of development and implementation of Quality Management Systems in Lean/6 Sigma manufacturing environments.
Widespread knowledge and understanding of pharmaceutical production, plant design and operation.
Extensive experience of Worldwide Regulatory Agency GMP/GDP expectations and current knowledge and understanding of regulatory requirements for medicinal product development, manufacture, and distribution of API and licensed medicinal products. Hosted numerous regulatory inspections by the MHRA, VMD and FDA.
JAMES CULYER
Company Director and Principal Consultant
James is a Quality Consultant and Qualified Person (since 2010) with over 20 years’ experience in technical, quality and managerial roles within parenteral, non-sterile liquid, oral solid dosage, and inhalation product manufacture.
Extensive experience of managing all aspects of Manufacturing site Quality Management Systems. Specialist in Supply Chain Assurance activities and previously established Global Audit Schedules and Customer Complaints processes for a Multinational company.
Practical experience of a wide range of medicinal product dosage forms – Tablets, Capsules, Powders, Sterile Injections (large volume parenterals, vials, ampoules), transdermal patches, oral non-sterile liquids, inhalation products (pMDI), and creams and ointments. Also experienced in Medical Devices and Medical Device Quality Management.
Real life experience of green field and facility redesign projects, giving GMP input into design, construction, and finishing of new sterile & non-sterile facilities.