Welcome to Driftpin Consulting
Driftpin Consulting helps life sciences organizations navigate the complexities of compliance, regulatory frameworks, and system validation. From ISO certifications to GxP compliance, we ensure your success in a competitive landscape.
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- ISO Certification: Strengthening compliance and operational excellence. Achieve ISO 9001 or ISO 27001 certification with confidence.
- GxP Compliance: Ensure adherence to Good Manufacturing Practices (GMP) and regulatory requirements.
- System Implementation: Streamline clinical technology systems for seamless operation.
- Strategic Guidance: Navigate complex decisions with expert insights.
- Software Validation: Delivering validated and compliant solutions.
- System Implementation: Enhancing research efficiency through tailored solutions.
- Change Management: Driving organizational resilience and innovation.
Why Choose Us?
- Proven expertise in the life sciences sector.
- Customized solutions tailored to your organization’s needs.
- A track record of success with biotech, pharma, and clinical technology providers.
Who We Are
At the forefront of life sciences consultancy, we specialize in enhancing technology utilization for our diverse clientele, including pharmaceutical companies, biotechnology firms, and Clinical Research Organizations (CROs).
Driftpin is dedicated to identifying technology requirements, designing tailored solutions, evaluating vendors, and overseeing the full lifecycle of system implementation and validation. We ensure that systems are efficiently managed and maintained throughout their operational lifespan.
How We Help
For Life Sciences Organizations
- ISO Certification: Navigate the intricate journey toward ISO 9001 and ISO 27001 certifications with a tailored approach that aligns compliance and quality assurance with operational efficiency.
- Software Validation: Delivering validated and compliant solutions. Ensure your software systems meet rigorous life sciences requirements through a streamlined Computer System Validation (CSV) process, integrating User Acceptance Testing (UAT) and Performance Qualification (PQ).
- System Implementation: Enhancing research efficiency through tailored solutions. Simplify software adoption and lifecycle management for R&D programs while ensuring seamless integration and regulatory compliance.
- Change Management: Driving organizational resilience and innovation. Transform change into a strategic advantage with holistic solutions that encompass people, processes, and technology.
For Technology Vendors
We assist GxP Software Manufacturers by modifying your quality, security, compliance, and validation processes, allowing your tea to focus on delivering systems that solve your clients’ problems.
We do this by:
- Defining unique value propositions specific to your business needs
- Establishing a sustainable validation compliance strategy that minimizes your client’s validation overhead
- Creating the foundation of Quality Management and/or Information Security to create benefit for the organization and take the first steps toward ISO certification
- If you are ready, we can guide your team to attain ISO ISO 27001 or 9001 certification
- Taking leadership roles during client implementations, providing tactical and strategic insights across implementation, data migration, system integration, training, documentation, and project managment. We can also help you with client management:
- Conducting discovery sessions at project outset, which allows you to nail down scope, provide attainable delivery timelines, and generate a budget that is fair and removes the need for periodic change orders
- Establishing clear stakeholder communications ensuring consistent expectations, honest reporting of issues, and the basis for longer term partnership
- Enabling a reliable and accurate change management program that ensures the client’s organization understands the areas of change that may impact your system.
- Cultivating strong client relationships to ensure long-term success.
Partners
Success Stories
- CellPort ISO 9001 Compliance: Seamless compliance for clinical systems.
- Vertex Risk Mitigation: Reducing risks with innovative strategies.
Get in Touch
- Call: +1 267-204-3524
- Email: info@driftpin.com
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