Pharmacovigilance consultant
Expert consulting services to take your business to the next level
Windsteer
Pharmacovigilance Consulting Services
Windsteer is a leading provider of specialized pharmacovigilance services for small to medium enterprises in the biotechnology/pharmaceutical and clinical research industries.
We offer a wide range of supportive services, including: UK Local QPPV; PV Audit; Gap analysis, SOP writing and updating, SDEA authoring and negotiation, aggregate report writing, interim team management, team resourcing and vendor management, CCDS writing and updating, signal detection and validation, as well as case processing and quality control.
About Windsteer
Our Mission
At Windsteer we specialise in providing top-tier pharmacovigilance consulting services.
Our expertise lies in working with companies or teams who need specialised PV support or knowledge.
We recognise that the patient should be at the heart of everything we do.
Our Services
Jo Elsden has more than 20 years experience in pharmacovigilance and product safety.
She has worked in big pharma and clinical research operations, and managed PV throughout the lifecycle of the products. Browse our services to learn more about what we offer.
Our Approach
At Windsteer, we take a collaborative approach to consulting. We work closely with our clients to understand their needs and develop solutions that are tailored to their unique challenges.
Our methodology is transparent, results-driven, and designed to help businesses succeed.
Pharmacovigilance Services from Windsteer
UK Local QPPV Services
UK Local QPPV Services
UK Local QPPV Services
We offer dedicated UK Local Qualified Person for Pharmacovigilance (QPPV) services. Our expertise ensures that your pharmacovigilance operations comply with UK regulations while maintaining high standards of safety and efficacy. We are committed to safeguarding your patients and your business.
Gap Analysis
UK Local QPPV Services
UK Local QPPV Services
Our comprehensive gap analyses are designed to identify areas for improvement in your processes. We provide a detailed assessment of your current practises and recommend actionable steps to enhance your pharmacovigilance system, ensuring optimal compliance and safety management.
GVP Auditing
UK Local QPPV Services
Vendor Management Solutions
Our GVP auditing services are designed to ensure that your PV system complies with regulatory requirements and industry best practices. We conduct thorough, independent and well documented audits to evaluate the effectiveness of your PV system.
Vendor Management Solutions
Vendor Management Solutions
Vendor Management Solutions
Effective vendor management is crucial for successful pharmacovigilance operations. AWe provide solutions that streamline your vendor selection process, ensure compliance, and enhance collaboration. Our team will work with you to establish and maintain strong relationships with vendors, guaranteeing quality and efficiency in your pharmacovigilance activities.
SOP Writing and Updates
Vendor Management Solutions
SOP Writing and Updates
At Windsteer Consultancy Ltd, we understand the importance of having well-defined Standard Operating Procedures (SOPs) in place. Our team provides expert assistance in writing and updating SOPs to reflect current practises and regulatory standards. This ensures your organisation operates smoothly and adheres to compliance requirements consistently.
Interim Team Management
Vendor Management Solutions
SOP Writing and Updates
If you require interim team management, Windsteer Consultancy Ltd is here to help. Our consultants have extensive experience in leading pharmacovigilance teams during transitions or critical periods. We ensure seamless operations while maintaining high standards of quality and compliance. Let us provide the leadership and support your team needs to thrive during challenging times.