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:

AE/SAE reporting systems, especially SUSAR reporting

Every type of clinical audits, vendor audits

Computer system validation (CSV)

Translations

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

Audits

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

SOPs

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

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

Get in touch with us