FDA Remediation

Our consultant Quality, Control & Remediation Practice aspires to transform pharma and medical device industry clients into the benchmark of high quality in order to save patient lives, avoid supply chain disruption, and enable operations excellence - at optimal cost to our clients.

We help answer client questions around uncovering the root cause –not just the technical or compliance defect - on how to allocate resources, simplify the outcome, and drive to become a world-class business. We offer clients deep compliance experience, manufacturing and quality leadership, transformation expertise, business perspective, and top tier values.

The FDA Remediation practice achieves compliance and quality through process, capabilities, culture and design; a focus on high-risk areas both from a patient as well as a business perspective, solving the underlying quality and compliance challenges, and ensuring a sustainable business model after implementing solutions.

Our consultant Expert had deep experience and relationships at the FDA and/or other notified bodies, who has hands-on experience conducting and leading large scale inspections; depth within the risk and regulatory space; and proven skills in managing FDA inspections, from the view of the FDA. This individual will help build Compliance capabilities, while also leading clients to understand and address their quality and compliance challenges through the application of regulatory and/or technical expertise. In addition we also deliver long term, transformative risk and regulatory solutions for clients in the Operations and Pharmaceutical/Medical Products space, providing distinctive client impact on CEO-level issues.

Our experts play a key role in consulting teams, often working with multiple project teams across a dynamic set of situations in a way that leverages their deep knowledge in a specific area. They apply a broad range of creative problem-solving skills, combining deep technical and analytical excellence to help solve their piece of the overall client puzzle. They push both their coworkers and our clients in thinking about challenging situations in new and transformative ways.

In addition our Experts work with senior leaders, identifying gaps and opportunities to apply frameworks that substantially improve performance in key areas. They integrate at multiple points in a style, leading workshops to help build a change story or vision, often leading longer term engagements with teams, such as setting the agenda, synthesizing output and assisting in carrying out the study. In addition, they develop short and long-term plans for all relevant levels of client leadership, with anticipated deliverables, outcomes, and required resources to sustain the transformation.

Resolving your compliance issues is our motto.

When your organizations are facing difficult challenges, and has earned a solid reputation for delivering high-quality insight and recommendations to overcome those challenges. Choose only end to end remediation solution Source life science Consultants when you need help who will help you in

  • Responding to an FDA 483 inspection.
  • Responding to an FDA Warning Letter.
  • Meeting with the FDA to resolve disputes.
  • Implementing corrective and preventive action (CAPA) programs-including development, execution, monitoring, and project management.