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.
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, based upon long experience with audit processes.
We organize our services to cover your specific business needs.
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..
We can handle all GDP tasks from § 39 application, temperature mapping, preparation of necessary instructions and establishment of a quality system.
Are you considering implementing ISO 9001 or ISO 17025, we 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.
Are you in lack of teaching resources or do you need specialized training of your staff, we 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.
Project management or support to present project management, advice within GMDP or ISO, please contact us for further dialog.
GxP-Pharma Support A/S ensures a good momentum and clear communication between the project team and project management, an extra resource for You.
QA, RP & QP Services
Does your company need more resources or technical support in quality aspects? If so, we can add additional resources.
We support QA, RP & QP qualified services with release of drugs, QA support tasks and QA approvals. We support quality requirements within pharmacovigilance and other quality systems.