Revitalizing Compliance: Pharma's Journey to Business Resurgence

Greenmile's Comprehensive Cultural Transformation Revives Business After Overcoming FDA Import Alert for a Pharma Major.

Greenmile

2/26/20232 min read

Greenmile's Comprehensive Cultural Transformation Revives Business After Overcoming FDA Import Alert for a Pharma Major.

The Challenge: Navigating Regulatory Challenges Post-FDA Alert

In the aftermath of an FDA import alert, a pharmaceutical company faced significant regulatory hurdles, jeopardizing its standing in the industry. Greenmile was entrusted with the crucial task of orchestrating a cultural transformation, focusing on compliance, to reclaim the company's business and reputation.

Strategic Measures: Cultivating Compliance and Cultural Transformation

Greenmile's intervention comprised a comprehensive HyPE (High Performance Enterprise) model implementation:

1. Strategic Consulting: Collaborative sessions were conducted to strategize and align the company's operations with compliance standards, ensuring a robust and sustainable approach.

2. Employee Training: All employees underwent targeted training sessions, equipping them with the knowledge and skills needed to adhere to compliance requirements.

3. Team Scorecard & Culture Index: Metrics for compliance were integrated into a team scorecard, fostering a culture of accountability and continuous improvement.

4. Cultural Transformation at the Shopfloor: Greenmile provided hands-on support for cultural transformation at the shopfloor, instilling a compliance-focused mindset among the workforce.

Transformation Realized: From Setback to Success

The impact of Greenmile's efforts was profound and far-reaching:

• Ideal Structure with Focus on Compliance: The company adopted an ideal organizational structure with a laser focus on compliance and accountability, aligning every facet of its operations with regulatory standards.

• Detailed Competency & Cultural Assessment: Greenmile conducted thorough assessments of competency and culture, tailoring interventions to address specific areas of improvement.

• Regaining Business in the US: The pharmaceutical company not only regained its business in the US market but also navigated through multiple FDA audits, including a surprise audit, with flying colors.

Highlight: A Resilient Comeback in the Pharma Landscape

Greenmile's cultural transformation expertise became the catalyst for the pharmaceutical company's resilient comeback. By instilling a culture of compliance and accountability, the company not only regained its business but also emerged stronger and more resilient in the face of regulatory challenges.