Consulting > Qualified Person Services
Service Overview
GxP Consulting is able to provide the Qualified Person (QP) support that your business needs, either to complete a specific assignment or on an ongoing basis. Our Qualified Person and Regulatory Compliance team collectively has experience and knowledge of completing hundreds of regulatory inspections by the MHRA, EMEA, FDA and CDA and can provide your business with the support it needs during the application and maintenance of licence approval.
With many years in the pharmaceutical industry and government services, our consultants are familiar with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Distribution Practice (GDP) and Good Pharmacovigilance Practice (GPvP). Our team can support your business with applications for clinical trials, new product licences and variations for existing licensed products. Help is available on Manufacturer’s, Wholesale Dealer’s and “Specials” Licences.
The QP will cover both Human and Veterinary Medicinal Products, including those for export. As expected, the wider technical, ethical, and professional obligations in terms of patient safety, quality and efficacy are always considered. Any areas of deficiency will be pointed out, and arrangements made with management to have them corrected. Our aim is to develop a culture of continuous improvement that anticipates any regulatory requirements and maintains proper protection for the patient as well as the reputation of the manufacturer.
Strategic consulting
- Planning and support with Investigative Medicinal Product (IMP) applications and clinical study setup and management
- New product introduction (NPI) and licence application
- New facility approval
- Pre-inspection auditing and remediation
- Support with regulatory approval for the introduction of novel technology or products
- Assessment of strategy and impact of opening new markets for existing products
- Helping businesses understand their regulatory compliance responsibilities as defined by the FDA, EMEA, MHRA, WHO, HTA and interpretation of guides such as the UK Orange Guide
Tactical services
- Interim QP services
- Part-time, ongoing QP support
- QP training and coaching
- QP support for clinical trial management, including preparation of the Product Specification File
- Marketing Authorisation (MA) licence application for introduction of new product or product variation
- Wholesale Dealers Licence (WL) application and provision of Responsible Person (RP) support as defined by Good Distribution Practice (GDP)
- Development and implementation of Quality Management Systems (QMS)
- Development and implementation of internal and third-party service provider auditing systems, preparing Technical Agreements (TA) and Service Level Agreements (SLA)
