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.