PMK Pharma Consulting

We are working successfully in all areas of clinical research since 1993

Quality Assurance/ Management – Audits – SOPs – Validation

Consulting

PMK offers worldwide advice in the field of drug development, clinical evaluation of medical devices, qualification and validation in the GMP regulated area

Research & Investigation

We offer research in a variety of medical databases.

References

According to a lot of publications, we have special experiences in the following areas:

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AE/SAE reporting systems, especially SUSAR reporting

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Every type of clinical audits, vendor audits

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Computer system validation (CSV)

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Translations

English, Spanish, Swedish, French, Czech, Bulgarian, Romanian and Russian …

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Audits

Pre-Trial, In-house Audit Sponsor/CRO, On-site, Phase I Hospitals, Data Management, Biostatistics, Summary Report, Vendor Audits, Auditzertifikat…

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SOPs

every type of own developed SOPs for Clinical Studies, Quality Assurance, Pharmacovigilance Systems,  Quality Management Systems …

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System Validation

System development, documentation, installation, testing, reporting according to the V-Model (GAMP 5)  …

About us

Since 1993, we have been working successfully in all areas of clinical research, especially quality assurance/audits, and also prepare scientific translations.

Since 1999, we have also been advising in the field of system validation (computer, manufacturing machines, laboratory information management [LIMS], document management systems [DMS], ERP [SAP], etc.) and the necessary infrastructure, creating corresponding SOPs, compile documentation, create validation master plans, test scenarios (IQ, OQ, PQ) and also carry out tests ourselves.

Quality Assurance in Clinical Research

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