Welcome to PR QualityConsultancy GmbH

PR QualityConsultancy GmbH is a company for consultancy in all fields of pharmaceutical / biopharmaceutical /medical device manufacturing and related businesses worldwide.

You need additional expertise or qualified resources for your company or you have a problem related to manufacturing, PR QualityConsultancy can support you with solutions and assessements using Lean SixSigma, GMP-Audits or providing projectmanagement.

Quality and motivation for effective and efficient solutions is the expertise of PR QualityConsultancy. Audits are performed with the goal of gaining value to all parties: Customers get an overview on the real quality standards of their suppliers and the supplier recieves advice and support to improve their product-quality from an independent company.

"No audit-tourism": The overall costs and time-consumption for organizing, planning, travelling and performing qualified audits are too high for all participating parties to be performed without adding value to an organization.

PR QualityConsultancy has the target to contribute value, to be truthful and reliable internal as well as confidential external.

Audits can be performed independent or in combination with your own experts.

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Pia Radmer

About the network

My company is oriented to improve the quality of my  customers in the field of manufacturing and supplier/CMO quality worldwide. This covers process improvement, quality  assessment and technical root cause investigation.

Over 16 years technical experience in pharmaceutical and chemical technology / engineering, R&D and commercial manufacturing processes as well as quality systems, worldwide supplier-assessment/development and trouble shooting mainly in English or German language.

My educational background is a scientific BSc,MSc / Dipl.-Ing. (Univ.) in BioChemical process engineering from the University of Stuttgart with the main subjects biotechnology, biomedical engineering and chemical reaction engineering. I have 8 years experience as GMP-Lead Auditor worldwide (ECA/APIC-certified; America, Europe, Asia, Australia), hosting authority inspections or for-cause audits by customers, as Lean SixSigma Black Belt and overall 12 years experience in the global pharmaceutical and biotechnology business, with an overview from more than 120 manufacturing sites. This includes 'TOP 10 - big pharma' as well as smaller Biotechnology companies

The network can contribute additional expertise and resources to meet customer's needs. For example, language support for different countries. Our customers are our best proof for quality. We appreciate to be also your contact of choice.






GMP Audits

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The following service is provided in sterile and non-sterile GMP-manufacturing of bio-/ pharmaceutical API (active pharmaceutical ingredients) and production of FDF (finished dosage forms - liquid/ oral) as well as pharmaceutical excipients and medical devices. Additional this service can be applied in all related supplying businesses (manufacturing equipment and raw materials, clean-rooms, primary and secondary packaging, detergents, disinfectants, disposable equipments etc.)

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Interim-Management / Project Management / Audits / 

CMO "Person-in-plant" support

Technical Expert, Team/Department Lead/Development, Project Lead, Compliance Expert

Topics of Expertise (Overview):
  • Technology Transfers, Supplier Qualification for New Product Launches etc.
  • Quality assessment of your manufacturing-site (worldwide GMP-audits)
  • Quality assessment of your suppliers/CMO manufacturing site (worldwide audits: due diligence audits, routine audits, for-cause audits)
  • Lean projects and scientific optimization of your manufacturing processes (SixSigma)
  • Support for improving quality systems / remediation initiatives (worldwide cGMP's, EU-GuidelinesUS FDA -Guidelines, etc.)
  • Regulatory compliance projects for preparation of authority inspections
  • Support for equipment qualification
  • Support for validation of manufacturing processes, cleaning validation
  • Risk assessments (FMEA etc.)
  • Technical root cause investigations and trouble shooting internal sites and at suppliers
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Project Overview

- exact project details are confidential -

Reference 1
Senior Consultant: Inspection readiness (US-FDA) compliance of global organization of CAPA-system (EMEA-locations) Strategy, legacy overview, remediation and training of sites.
Lead GMP-Auditor Vaccine / Biopharma CMO-Development - Manufacturing DS/DP including suppliers. (Various customers) USP/DSP Process Development for clinical studies, Technology Transfers and commercial manufacturing. Training/Coaching of Junior-Auditors.
Interim Manager Process Validation / Human vaccine / biotechnological API-manufacturing / mammalian Cell-Culture. CMC-Technology Transfer to CMO - Clinical Phase III - New Product Launch (International organization), different risk assessments, including GMP-audits for supplier qualification and GMP-compliance support. [FDA Guidance for Industry "Process Validation" Stage 2: PPQ-Readiness and Validation]
Compliance-project: Inspection Readiness (FDA, EMA, etc.) - Remediation of Deviation/CAPA-system / subject matter expert / continuous improvement / root-cause investigations / product risk assessment etc. [EN ISO 13485:2012; FDA 21 CFR part 820; Class III sterile medical devices; human implants, etc.]
CMC - Technology Transfer (R&D to GMP-production, Clinical Phase III, New product launch), Risk Assessment, cleaning validation, statistical data assessment in aseptic biopharmaceutical manufacturing FDF - liquid sterile cartriges. [FDA-Guidance for Industry "Process validation" - Stage 1: Quality by Design - ICH Q8/Q9/Q10, etc.]
Senior Consultant: CAPA compliance / legacy review / remediation / subject matter expert in manufacturing of surgery implants, human biomaterials and combination products (class III medical devices), organization change management, investigations continuous improvements etc. (FDA-warning letter / Concent degree) [EN ISO 13485:2012; FDA 21 CFR part 820; Class III sterile medical devices; human implants & biomaterials, etc.]
Implementation of Continuous process verification (CPV) in aseptic manufacturing of biopharmaceutical / biologics drug product (liquid, lyo) according to FDA-Guidance for industry "Process validation" - Stage 3: Process Capability CpK-value, statistical data analysis [ICH Q9/Q10, etc.]
Hosting and guiding different inspections by authorities and for 'for cause audits` by customers (CMO business). Including CAPA-Plan assessment.
Post aquisition audits (PAA) at worldwide sites after company-merger. (Pharmaceuticals, diagnostics, medical devices) - including CAPA-plan assessment and Quality Compliance.
Compliance and "for-cause" Audits of most cell culture media suppliers worldwide (Biopharmaceuticals) - including CAPA-Plan assessment.
International supplier qualification and supplier development (Biopharmaceuticals) - CAPA-plan assessment and Quality Compliance.
International GMP-Audits of contract manufacturers (CMO) for sterile finished dosage forms (cytostatics, biologics, biosimilars, etc. - syringes, vials, ampoules - liquid and lyophilized) including Quality Compliance.
GMP-compliance-Audits of chemical API manufacturers in China [ICH Q7, etc.].
QA-supervision of investment projects in pharmaceutical manufacturing (FOYA: factory of the year 2012).
QA-supervision of cell culture development for manufacturing of biologics [ICH Q7a, etc.] including all aspects of Quality Compliance.
New product launch New product launch in prefilled syringes: Process validation, qualification of equipment, technical trouble shooting, root cause investigations and risk assessments in aseptic biopharmaceutical manufacturing (FDF).
FDA-compliance technical projects in commercial pharmaceutical manufacturing, process design and trouble shooting.
Continuous process verification in sterile manufacturing according to FDA-guideline using Minitab- Statistic software
Cleaning validation in biopharmaceutical manufacturing of API/Biologics/DS according to ICH Q7a etc.
Audits of manufacturers for disposable systems (polymer systems for biopharmaceutical manufacturing) - including CAPA-plan assessment and Quality Compliance.
Training of personnel in risk assessments/ FMEA. (sterile biopharmaceutical processes)
Technical qualification of pharmaceutical process equipment and utilities (WFI-systems, HVAC, etc.).
Product process validations in biopharmaceutical manufacturing of API/Biologics/DS.
Development of GMP-system at smaller biotechnology company - CMO. (Deviations, Change Control, Supplier qualification etc.) including all aspects of quality compliance.
Development of a pervaporative Membrane bioreactor (R&D-Environment). Publication: Journal of membrane science (Elsevier)
Development of a hollow-fiber bioreactor for expansion of hemopoietic stem cells CD34+ / mass transfer simulation. (company scholarship - R&D-Environment)
Process development of construction prototypes for car -motor-cooling system (commercial launch).
Thermodynamic heat transfer calculations for pharmaceutical plant engineering (commercial launch).

How to get in contact

If you have a project and want to get in touch with us for discussion, please fill the form and we will organize a first meeting for evaluation.


Get in Contact

  +49 163 2594 693


  Dufaux Strasse 2; CH-8152 Zürich-Glattpark

  Robert-Bosch Str. 26; D-64293 Darmstadt

Pia Radmer Contact

Pia Radmer


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