GXP Pharma Support
GxP-Pharma Support A/S is a professional and flexible pharmaceutical consulting firm dedicated to providing expert support and consultancy in GxP, GMP, GDP, ISO standards, and other quality models. With over 20 years of experience, the company offers tailored services including audits, compliance checks, project management, training, and resource support to ensure clients meet regulatory requirements and improve their quality systems. Their mission is to create trust and deliver practical, sustainable solutions, aiming to be the preferred and trustworthy partner for the pharmaceutical industry now and in the future.
Industries
Nr. of Employees
small (1-50)
GXP Pharma Support
Products
GMP
Specialized audit of suppliers and contractors, compliance checks, and upgrading of GMDP quality systems including necessary documentation.
GMP consulting services
Professional support and consulting within Good Manufacturing Practice (GMP) for the pharmaceutical industry, leveraging international production and regulatory authority experience.
GDP
Compliance check of quality systems and implementation of risk assessment, deviation handling, change control, and management evaluation.
GDP – Good Distribution Practice
Comprehensive GDP compliance check, GAP analysis, and audit services for quality systems, storage facilities, and transport routes in the supply chain.
ISO
Advisory and implementation process for ISO 9001 or ISO 17025 with GAP analysis, audit, and documentation.
ISO 9001 consulting and implementation
Full implementation service for the ISO 9001 quality standard including gap analysis, documentation, training, and audit support.
GMP
Specialized audit of suppliers and contractors, compliance checks, and upgrading of GMDP quality systems including necessary documentation.
GMP consulting services
Professional support and consulting within Good Manufacturing Practice (GMP) for the pharmaceutical industry, leveraging international production and regulatory authority experience.
GDP
Compliance check of quality systems and implementation of risk assessment, deviation handling, change control, and management evaluation.
GDP – Good Distribution Practice
Comprehensive GDP compliance check, GAP analysis, and audit services for quality systems, storage facilities, and transport routes in the supply chain.
ISO
Advisory and implementation process for ISO 9001 or ISO 17025 with GAP analysis, audit, and documentation.
ISO 9001 consulting and implementation
Full implementation service for the ISO 9001 quality standard including gap analysis, documentation, training, and audit support.
Services
On-site audits of manufacturing sites, suppliers and contract manufacturers with reporting and remediation planning.
End-to-end support for distribution companies including §39 application preparation, temperature mapping, QMS implementation and audit of transport routes and warehouses.
GAP analysis, documentation development, training and pre-audit support for ISO 9001 and ISO 17025 accreditation.
Tailored GxP training for different personnel groups covering GMP, GDP, GVP, documentation, risk assessment and role-specific tasks; delivered on-site or at client facilities.
Provision of dedicated project management for technology implementation, QMS upgrades, LEAN initiatives, IT system deployments and site licensing projects.
Supply of Responsible Person (RP), Qualified Person (QP) and QA resource personnel on interim or part-time basis with contractual documentation to meet regulatory delegation requirements.
On-site audits of manufacturing sites, suppliers and contract manufacturers with reporting and remediation planning.
End-to-end support for distribution companies including §39 application preparation, temperature mapping, QMS implementation and audit of transport routes and warehouses.
GAP analysis, documentation development, training and pre-audit support for ISO 9001 and ISO 17025 accreditation.
Tailored GxP training for different personnel groups covering GMP, GDP, GVP, documentation, risk assessment and role-specific tasks; delivered on-site or at client facilities.
Provision of dedicated project management for technology implementation, QMS upgrades, LEAN initiatives, IT system deployments and site licensing projects.
Supply of Responsible Person (RP), Qualified Person (QP) and QA resource personnel on interim or part-time basis with contractual documentation to meet regulatory delegation requirements.
Expertise Areas
- GMP auditing and compliance
- GDP and distribution compliance
- Quality management systems (GMDP/ISO) implementation
- Project management for GxP projects
Key Technologies
- Risk assessment methodologies (ICH Q8/Q9/Q10/Q11 approaches)
- Temperature mapping and cold-chain qualification
- Quality Management Systems (QMS) implementation
- GAP analysis and mock audit methodologies
News & Updates
Latest news and updates from the Danish Medicines Agency and EMA.
New guideline on sterilization of medicines, APIs, excipients, and primary packaging.
Guidelines and updates on data integrity from various authorities including FDA, MHRA, and EMA.
Updates and news on Good Distribution Practice, including certification and compliance.
Updates on EU GMP annex 15 regarding validation and qualification.
Information on updates to EU GMP Annex 15 and validation requirements.
Latest news and updates from the Danish Medicines Agency and EMA.
New guideline on sterilization of medicines, APIs, excipients, and primary packaging.
Guidelines and updates on data integrity from various authorities including FDA, MHRA, and EMA.
Updates and news on Good Distribution Practice, including certification and compliance.
Updates on EU GMP annex 15 regarding validation and qualification.
Information on updates to EU GMP Annex 15 and validation requirements.