Paradigm Shift Consulting
Paradigm Shift Consulting Ltd is an ISO 9001:2015 accredited consultancy providing training and quality management services to the pharmaceutical industry, specializing in Good Distribution Practice, Wholesaling activities, and compliance support. They offer bespoke support, training, audits, and consultancy to help companies achieve and maintain regulatory compliance, improve operational processes, and expand their business in the pharmaceutical sector.
Industries
Nr. of Employees
small (1-50)
Paradigm Shift Consulting
Rushden, Northamptonshire, United Kingdom, Europe
Services
Provision of named or contracted deputy Responsible Persons for wholesale licences with ongoing oversight, remote support and scheduled site visits.
Bespoke GDP training courses for all staff levels, delivered in-person, via webinar or through online courses with certificated assessments.
Review, remediation or creation of Quality Management Systems and SOPs, including document control, forms and work instructions compliant with GDP.
Third-party GDP audits, 3PL audits, gap analyses against EU guidance, pre-inspection reviews and remote audits following MHRA protocols.
Corrective action planning and hands-on support to address regulatory suspensions or inspections, including liaison with inspectorates and IAG.
Assistance with Wholesale Distribution Authorisation applications, documentation preparation and inspection readiness support through to inspection.
Provision of named or contracted deputy Responsible Persons for wholesale licences with ongoing oversight, remote support and scheduled site visits.
Bespoke GDP training courses for all staff levels, delivered in-person, via webinar or through online courses with certificated assessments.
Review, remediation or creation of Quality Management Systems and SOPs, including document control, forms and work instructions compliant with GDP.
Third-party GDP audits, 3PL audits, gap analyses against EU guidance, pre-inspection reviews and remote audits following MHRA protocols.
Corrective action planning and hands-on support to address regulatory suspensions or inspections, including liaison with inspectorates and IAG.
Assistance with Wholesale Distribution Authorisation applications, documentation preparation and inspection readiness support through to inspection.
Expertise Areas
- Good Distribution Practice (GDP) compliance
- MHRA inspection remediation and regulatory liaison
- Quality Management Systems (QMS) and SOP development
- Responsible Person (RP) services and oversight
Key Technologies
- Online training platforms and webinar delivery
- Remote/virtual auditing tools and workflows
- Temperature mapping and cold-chain monitoring
- Quality Management System frameworks
News & Updates
Don’t let common GDP audit findings derail your compliance efforts. Discover proactive strategies to anticipate and address deficiencies before they become major issues. Learn how to transform potential pitfalls into compliance wins.
Counterfeit and falsified medicines are a global problem that poses serious risks to public health and safety. They are products that are deliberately and fraudulently mislabelled with respect to their identity.
Cold Chain is the process of maintaining the quality and integrity of medicines that require lower than ambient temperatures in storage and transportation.
Change control in GDP is a process used to manage any changes that may affect the compliance with Good Distribution Practice. GDP guidelines ensure proper storage, transport, and handling conditions.
Outsourcing in the pharmaceutical industry offers benefits but also poses challenges and risks. Proper management of outsourced activities is essential for compliance and quality.
In the evolving pharmaceutical supply chain, GDP UK is crucial for ensuring the quality and safety of medicines from manufacturer to end user.
Don’t let common GDP audit findings derail your compliance efforts. Discover proactive strategies to anticipate and address deficiencies before they become major issues. Learn how to transform potential pitfalls into compliance wins.
Counterfeit and falsified medicines are a global problem that poses serious risks to public health and safety. They are products that are deliberately and fraudulently mislabelled with respect to their identity.
Cold Chain is the process of maintaining the quality and integrity of medicines that require lower than ambient temperatures in storage and transportation.
Change control in GDP is a process used to manage any changes that may affect the compliance with Good Distribution Practice. GDP guidelines ensure proper storage, transport, and handling conditions.
Outsourcing in the pharmaceutical industry offers benefits but also poses challenges and risks. Proper management of outsourced activities is essential for compliance and quality.
In the evolving pharmaceutical supply chain, GDP UK is crucial for ensuring the quality and safety of medicines from manufacturer to end user.