Services
Your dedicated Independent Life Science Consultant with over 15 years of experience specializing in Pharmacovigilance, Medical Information, and Veterinary Pharmacovigilance. I offer a range of services tailored to meet your specific needs and ensure compliance, efficiency, and effectiveness in your operations.
Pharmacovigilance Services
- System Implementation: Successful implementation of effective and efficient Pharmacovigilance & Medical Information Systems.
- Audit & Inspection Readiness: Preparation and development of storyboards and playbooks for audits and inspections.
- Process Streamlining: Merging multiple Pharmacovigilance systems and establishing streamlined PV systems, including QPPV offices and LSOs.
- Training & Development: Creation of comprehensive PV & GVP Training Modules and courses to enhance knowledge and skills.
- Agreement Harmonization: Business process harmonization of Pharmacovigilance Agreements for better alignment and efficiency.
Medical Information Services
- Data Integrity: Ensuring the accuracy and reliability of your medical information data.
- Operational Efficiency: Evaluating and enhancing your medical information management processes.
- Regulatory Compliance: Making sure your medical information practices adhere to all relevant regulations.
- Training Modules: Developing training programs to keep your team up-to-date with the latest industry standards.
Veterinary Pharmacovigilance Services
- Specialized Audits: Tailored reviews to address the unique challenges of veterinary pharmacovigilance.
- Compliance Assurance: Ensuring your veterinary pharmacovigilance systems are up to date with the latest regulations.
- Best Practices: Implementing industry best practices to improve your veterinary pharmacovigilance processes.
- Training & Support: Providing training and support to help your team navigate veterinary pharmacovigilance requirements.
Strategic Advisory Services
- Gap Analysis & Impact Assessment: Conducting thorough assessments to identify gaps and potential impacts.
- Vendor Assessment: Strategic vendor assessment and building out internal capabilities and roles.
- SOP Mapping: Workshops and integration for Standard Operating Procedures (SOP) mapping.
- Due Diligence Support: Assisting with due diligence during mergers and acquisitions.
Why work with me?
- Experience: Over 15 years of hands-on experience in consulting and auditing.
- Expertise: Deep knowledge of Pharmacovigilance, Medical Information, and Veterinary Pharmacovigilance.
- Collaborative Approach: I work closely with you to understand your needs and deliver tailored solutions.
- Commitment to Quality: Ensuring that your systems are robust, compliant, and efficient.
