Paar Pharma Consulting
Overview of Our Flow Chart and Case Studies of Our Services for Established Companies
Process flow
Our processes are carefully coordinated to ensure a smooth workflow during the implementation phase. We will guide you step by step through all the relevant aspects and provide you with personalized and comprehensive consulting.
Kick-off Meeting – Explanation of Objectives (e.g., Expansion of Manufacturing or Wholesale License)
Gap analysis to identify necessary activities and tasks (establishment of timelines and responsibilities)
Expansion/optimization of the quality management system
Conducting necessary audits of suppliers and service providers
Possibly communicating with authorities
Providing responsible personnel in case of resource constraints (e.g., QM management, qualified person, responsible person for wholesale and/or controlled substances)
Assistance with submitting the license expansion/application, communicating with authorities, addressing regulatory inquiries, and planning inspections
Conducting training sessions
Conducting a mock inspection for inspection preparation (if necessary)
Accompanying the inspection
Our support
Do you need support or have questions?
Our team is at your disposal and will be happy to advise you on topics related to quality management systems, analyses, certifications, and regulatory issues.
Case Studies
A medical device manufacturer requiring a wholesale license for pharmaceuticals
Establishment of a GDP-compliant quality management system within approximately 4 months and preparation for the inspection. Successful completion of the inspection and issuance of the license. Provision of the responsible person for wholesale and development of internal personnel to qualify for this position.
A medical device manufacturer requiring a manufacturing license for pharmaceuticals
Establishment of a GMP-compliant quality management system within approximately 5 months and preparation for the inspection. Successful completion of the inspection and issuance of the license.
Product Transfer to a Pharmaceutical Company
Assisting a pharmaceutical company with the transfer of a DNA-based drug product after licensing. Assessing the CMC (Chemistry, Manufacturing, and Controls) documentation and providing support for internal implementation.
Manufacturer of Investigational Medicinal Products/Sponsor of a Clinical Study
Providing support to the company in all Quality Assurance (QA) matters in the GMP/GCP areas and supplying the Qualified Person.
Contract Laboratory
Optimization of specific areas of the Quality Management System and regulatory consulting.
Archive service provider requiring a manufacturing license for pharmaceuticals
Establishment of a GMP-compliant Quality Management System within approximately 3 months and preparation for the acceptance inspection. Successful completion of the inspection and issuance of the license. Provision of the Qualified Person.
Your partner in the pharmaceutical industry
Our services
We provide clear, concrete assistance and solutions without hesitation and support you in your projects so that you can achieve your goals even faster.
Who we are
Our Team
Michael Paar
Owner / Principal Consultant
Nadin Stramka
Senior Consultant