A mid-size biotech company, facing critical FDA remediation and upcoming clinical milestones, required a rapid upscale in their quality and regulatory teams. With stringent timelines and the need for highly specialized talent, the company partnered with GQR to ensure these pivotal objectives were met.

Challenge

The biotech company was under significant pressure to address FDA concerns and advance its clinical trials. The challenges included:

• Tight Timelines: Fast-approaching deadlines to meet FDA remediation requirements and clinical trial milestones.

• Specialized Talent Needs: A critical shortage of specialized quality and regulatory professionals in the biotech sector.

• High Retention Requirement: The need for high retention rates to maintain project continuity and knowledge retention.

• Regulatory Compliance: Ensuring all contractors met stringent regulatory and compliance standards.

Solution

GQR, leveraging its deep expertise in the life sciences sector and innovative recruitment methodologies, implemented a strategic talent acquisition plan:

• Tailored Recruitment Strategy: Developed a customized recruitment plan focusing on identifying and attracting niche talent with specific expertise in quality and regulatory functions within the biotech industry.

• Specialized Talent Pool Access: Utilized GQR’s extensive network and database of specialized life sciences professionals to rapidly deploy qualified candidates.

• Comprehensive Support and Engagement: Implemented a robust contractor management and engagement program to ensure high retention rates, including continuous professional development, performance incentives, and regular feedback loops.

• Regulatory Compliance Assurance: Conducted thorough vetting processes to ensure all contractors met the required regulatory and compliance standards, facilitating seamless integration into the company’s quality and regulatory frameworks.

Results

GQR’s partnership with the biotech company resulted in:

• 95% Fill Rate: Successfully filled 95% of the required positions with highly specialized talent, significantly exceeding industry benchmarks.

• 90% Contractor Retention: Achieved a 90% retention rate for contractors, ensuring project continuity and knowledge retention.

• FDA Remediation and Clinical Milestones Met: The enhanced quality and regulatory teams played a pivotal role in addressing FDA concerns, allowing the company to meet all remediation timelines and advance its clinical trials as planned.

• Strengthened Regulatory Position: The company strengthened its regulatory compliance posture, positioning it for future success in its drug development and approval processes.

Conclusion

GQR’s strategic approach and deep specialization in the life sciences sector enabled the mid-size biotech company to overcome significant talent and regulatory challenges. By achieving a high fill rate and exceptional contractor retention, GQR ensured the company met critical FDA remediation requirements and clinical milestones, underscoring the value of a strategic talent partnership in navigating the complex regulatory landscape of the biotech industry.

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