Expert GDP Consultancy services
Mock GDP Inspections
Post inspection support and remediation activities
New application for a WDA(H) services
Tony can perform MHRA equivalent inspections to cater for your needs:
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A first mock inspection for a new Wholesale Dealer's Licence application inspection to ensure you are inspection ready.
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To prepare for an upcoming notified inspection to have a confidence check about inspection readiness.
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Understand the MHRA risk based inspection model and how it affects your business. A mock inspection will help identify how your business can mitigate risk factors and demonstrate compliance to reduce the number and duration of your inspections.
Have you had an inspection and need assistance as to how to respond? Tony can assist in mitigating the impact of the compliance gaps identified.
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Assistance with responding to the observation and understanding the extent of the response needed.
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Prepare an improvement plan and address the holistic nature of the deficiency.
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With 6 years experience as the GDP lead of the MHRA regulatory Inspection Action Group (IAG), Tony has seen numerous examples of inspections that have not been well managed both in the inspection and response phase and can help companies avoid the pitfalls when responding .
Tony can help you get your new licence application ready so that it is right first time to ensure that the inspection and assessment by MHRA will be completed within the 90 days assessment target.
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Help to prepare your Quality Management System and procedures.
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Gap analysis to ensure all areas of your business plan will be compliant with medicines Regulations and GDP.
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Train your staff and RP in what to expect at the inspection and how to prepare.
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How to ensure your application is flagged as a priority if it requires expediting.
GDP Consulting providing expert guidance, advice and Quality System and process review
Due Diligence and Supply chain investigations
GDP Third-Party outsourced activity
The Human Medicines Regulations are complex and challenging to understand. Tony with his many years of experience in contributing to the drafting of Regulations and guidance offers GDP consultation services to help you understand your obligations to ensure you are operating in line with legal requirements.
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Provides written opinions to support and justify decisions that impact your QMS and how the company operates.
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Advice on implementing the GDP Guidelines with practical assistance on how to implement the requirements of the 10 chapters.
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Provide an in-depth analysis of your current QMS and SOPs to examine if these are effective or inefficient and offer solutions to enhance, streamline, reduce cost and enhance quality.
Considering acquiring a new business?
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Tony can examine the compliance history, processes and records to verify any disclosures or identify potential compliance gaps.
Do you need support with investigations into suppliers' bona fides or customer order patterns that may be suspicious?
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Tony has extensive experience in the review of purchase and sales activity and the identification of what may be potentially falsified medicines supply or diversion from the legitimate supply chain.
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Tony can help you with external audits of your third-party suppliers or contract organisations that are required by GDP Chapter 7.
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Audits to review and monitor the performance of the contract acceptor.
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Initial assessment of the suitability and competence of a supplier.
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Assistance in preparing a contract and quality technical agreement.
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Understand what parts of your back office operation can be safely off-shored and remain GDP compliant.