Greenleaf Health expands its compliance and manufacturing portfolio to include remote quality and compliance support for clients.
Entities regulated by the FDA encounter challenges on a regular basis. But no recent challenge has placed as great of a strain on the life sciences industry as COVID-19. The impact of this global pandemic is experienced by companies of every size, and increased effort and adaptability are required from all parties to preserve the integrity of the supply chain and ensure a consistent supply of safe, high-quality products.
“Greenleaf Health recognizes that quality and compliance activities cannot be stalled. Despite global disruptions in surveillance inspections and other regulatory operations, Greenleaf’s work on behalf of our clients continues. The firm’s team of experts has identified opportunities to assist clients remotely while continuing to support all public health measures in effect throughout the course of the pandemic,” said John Taylor, President, Greenleaf Health, and Principal, Compliance and Regulatory Affairs.
Greenleaf’s remote compliance services concentrate on the FDA’s evolving alternative approaches to on-site inspections that may exist for many months to come. Although not a full substitution for on-site work, the remote opportunities provided by Greenleaf enable companies to continue essential quality and compliance activities while preparing for the time when on-site activities fully or partially resume.
STRATEGIC & TECHNICAL GUIDANCE
Greenleaf’s Product Quality, Manufacturing, and Compliance Team identifies and promotes practices and procedures that will align a client’s approach with the FDA’s quality, safety, and compliance expectations. Greenleaf also engages a network of independent contractors to provide technical expertise, both on site and remotely.
While companies face the complexities of navigating today’s challenging public health landscape, Greenleaf and our network of independent compliance experts are prepared to assist clients with the following remote quality and compliance services:
- Procedural and Record Review. Comprehensive review of new or revised Standard Operating Procedures (SOPs) for acceptability and compliance with requirements and objective evaluation of selected records (e.g., deviations, nonconformance reports, OOS, complaints) for accuracy, completeness, and compliance with requirements.
- Data and Trending Review. Examination of documents and objective feedback on key quality data and metrics, and trending reports prepared for quality or management reviews.
- Corrective Action Assessment. Evaluation of responses, corrective action records, and change control records related to issues identified by the client, or identified during previous inspections by the FDA and other health authorities, and determination of whether the actions are appropriate, complete, and effective.
- Regulatory Response Support. Objective review and expert guidance on providing effective responses to FDA 483s, warning letters, requests for additional information, and other critical regulatory correspondence.
- Issue-Specific Information. Review of information relating to a specific issue of interest identified by the client to provide an objective assessment and feedback to help with resolution, documentation, and communication.
- Training. Live video training on specific topics such as inspection preparedness, design controls, CAPA, etc.
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.
The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.
For more information on remote compliance services and Greenleaf Health, visit greenleafhealth.com.