A reliable partner
Supports multiple areas of production and quality systems
Audit of contract manufacturers and suppliers
Welcome to GxP-Pharma Support A/S
GxP-Pharma Support A/S offers a variety of consulting services to the pharmaceutical and biopharmaceutical industry and other organizations, subject to the requirements of the Danish Health and Medicines Authority, eg. blood banks, hospitals, doctors or other health professionals. Our expertise can be customized to cover your specific needs.
GMP
GxP-Pharma Support A/S specializes in audits of suppliers and contract manufacturers with reporting and contract preparation, compliance check and upgrade of GMDP quality systems incl. preparation of necessary documentation and reports. We organize our services to cover your specific business needs.
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GDP
GxP-Pharma Support A/S brings you on the right track with the new GDP guideline. We perform compliance check of your quality system and implement risk assessment, deviation handling, change control, management review etc.. Upon startup of a GDP company, we can handle all tasks from § 39 application to temperature mapping and preparation of necessary instructions and establishment of a quality system.Read More
ISO
Are you considering implementing ISO 9001 or ISO 17025, GxP-Pharma Support A/S advises you in the process. We provide complete implementation with GAP analysis, audit and subsequent preparation of the necessary documentation and records, to get your company ready for the certification. To complete the task, we assist you during the accreditation audit as your assessor.
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Training
Are you in lack of teaching resources or do you need specialized training of your staff, GxP-Pharma Support A/S organize training courses, taking into account your company's internal requirements and applicable regulatory requirements. We teach your staff from daily tasks, based on their daily work with known functions.
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Project Management
Does your project organization need a boost to reach deadlines or does you own project manager needs advice in project management or academic debate on GMDP or ISO, please contact us for further advice. GxP-Pharma Support A/S ensures a good momentum and clear communication between the project team and project management.
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Extra Resources
Does your company need more resources or technical support in quality aspects, GxP-Pharma Support A/S entry with an additional resource person. We offer among others QP expertise with release of drugs, QA routine tasks and QA approvals. In addition, we solve quality tasks within blood supply legislation, pharmacovigilance and other quality systems.
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