Sanapharm offers a unique combination of international Good Clinical Practice (GCP) and Good Pharmacovigilance (GVP) expertise. With our 19+ years experience in Clinical Development and Operations, Drug Safety, Medical Information and Medical Affairs across phase I-IV clinical trials at Astellas, Biogen, Novartis and F. Hoffmann La-Roche both locally and globally we are always in solution mode. Our additional expertise in transactional analysis (TA) is supplying us with collaborative tools to lead diverse teams, foster improvement processes and always aiming at operational excellence in a psychological safe business partnership providing practical and collaborative solutions.
Our list of consulting services:
• Quality Management System (QMS) Development and Maintenance incl. eQMS Solution Guidance and Implementation Support
• SOP and Policy Gap Analysis, Development and Implementation
• GCP and GVP Compliance Advisory
• Clinical Operations and Drug Safety Quality Oversight
• GxP Service Provider (e.g. CROs, Safety Services) Quality Management and Oversight
• Training Program Development and Delivery Support
• GCP and GVP Audit Planning, Execution and Remediation in collaboration with certified GxP Auditors
• Regulatory Inspection Preparation and Support
• Regulatory Agency Interaction Support (EMA, FDA, Health Canada, TGA, MHRA, PMDA, Swissmedic etc.)
• Risk Management and Inspection Readiness and Steadiness Consulting
• Strategic Quality Business Partnership at eye level and C-Level Leadership Support
The combination of international GCP and GVP expertise and the understanding that Quality by Design (QbD) is a competitive advantage because QbD is set up for failure without psychological safety.
Why? Because clinical teams don’t underestimate risks, they often don’t feel empowered to flag it. Your biggest warning sign is radio silence in the audience and employees no longer daring to speak up because raising quality concerns is not being rewarded, but punished.
Hence we believe psychological safety is a core ingredient to accomplish QbD in your clinical trials and our training in Transactional Analysis (TA) is supporting us in developing and fostering a psychologically safe environment. Without it your trail participant safety as well as your data integrity and credibility is going to be put at risk. Often followed by severe financial implications and a massive reputation loss and sometimes even a loss of your licence to operate. Good quality assurance is hard to measure - a rewarding system for reporting quality issues is a big leap into the right direction of QbD.
We offer tailored consulting and professional support, accompanied by workshops and trainings in the areas of GCP and GVP. Our services are primarily aimed at small pharmaceutical companies and biotech start-ups looking to transition from the preclinical phase to clinical phase I-II with their investigational medicinal drugs (IMPs) and investigational biological candidates. Such companies often need to acquire ad hoc QA expertise and seek support and we are here to partner with you.
Daliah Botzkowski has an international education and background and, thanks to her many years of professional experience, possesses a unique combination of GCP and GVP knowledge. With a comprehensive understanding of international and local requirements, different cultures and the perspectives of individual stakeholders, she is ideally placed to provide clients with sustainable and effective hands-on guidance and support.
Our clients include small pharmaceutical and biotech start-ups that are growing and/or facing quality challenges. We offer them support and technical expertise in GCP and GVP. We also assist hospitals, clinical trial units (CTUs) and non-growth organizations (NGOs) establishing minimum quality standards.
All pharmaceutical companies, even start-ups, must comply with numerous regulatory regulations in order to continue conducting clinical research and clinical trials.
Investing in QA support is therefore essential. Especially from clinical trial phase I onwards, trial participant safety and data integrity must be guaranteed at all times.
We provide support in identifying, assessing and managing risks relating to product quality and safety, propose risk management assessments and develop solution strategies.
Appropriate and individual quality assurance consulting and support can prevent failure in phase II due to a lack of professional QA consulting, especially in small pharmaceutical companies and biotech start-ups.
Are you looking for specialist QA expertise and support in the field of pharmaceuticals, biotechnology and drug development? We can assist you with our experience and know-how in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).
+49 179 9760199
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