Enabling dossier submission and regulatory approval and release of investigative and marketed products world-wide.
GxPi has many years of experience in advising on how to best meet the regulatory requirements of the MHRA, FDA, EMEA, CDA, HTA, WHO and ICH. Our consultants are highly skilled and experienced in identifying, communicating, managing and delivering your Good Manufacturing Practice (GMP), Good Automated Manufacturing Practice (GAMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GPvP) and Good Distribution Practice (GDP) requirements. GxPi is able to support with the QA management and responsibilities throughout your business including clinical studies, computer systems, manufacturing, packaging, warehouse and laboratory areas. By understanding your product, your process and your markets, we can advise on what you need to comply with and how to achieve this.
Our qualified person and regulatory compliance team collectively has experience and knowledge of completing hundreds of regulatory inspections and licence applications worldwide and can provide your business with the support it needs during the application and maintenance of licence approval.
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.
• Planning and support with clinical trail applications (CTA), investigative medicinal product (IMP) approval and clinical study setup and management
• New product introduction (NPI) and associated 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
• 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)
• Preparation of the site master file (SMF)
• 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) GMP risk assessment
• GMP impact assessment
• Contract QP services (interim, part-time or full-time options)
• Interim and part-time QA management support (on-site and remote services)
• Contract QA services (interim, part-time or full-time options)
• Clinical study project management
• eCTD preparation and submission
• Dossier compilation specialists
• Protocol and trial documentation management
• Document managers
• Technical writers