G&L utilizes decades of experience and a wealth of Subject Matter Expertise in Regulatory Affairs, Quality Assurance and Clinical Development to design and deliver solutions to the biggest challenges faced by global healthcare today. G&L’s reputation for designing and delivering highly effective solutions to the biggest challenges in global healthcare and our commitment to ensuring that our clients’ specific requirements are always met have seen the company experience phenomenal growth since our establishment in 2016.

From product development and submissions to company-wide change management, G&L Healthcare Advisors is proud to design, implement, and maintain high-quality, results-focused outcomes for everyone with whom we work.

As regulatory experts across the entire product lifecycle, we assist in early development, filing strategy, pre- and post-approval CMC, MAA/NDA support, publishing, post-approval lifecycle management (LCM), and global projects.

Whether you require specific technical skills, short or long-term temporary workload support, or a comprehensive project team, we would love to discuss your needs further.

On the Quality Assurance side – from clinical to commercial, our expertise will help you guarantee compliance, maintain oversight and eradicate risk, allowing you and your team to focus on your core deliverables.

We provide:
• QMS development and gap analysis
• Clinical trial audits and site inspection preparation
• Vendor management support
• Inspection readiness, including inspection support
• API and DP audits
• Remediation support
• eTMF gap analysis and audits
• Clinical trial material and commercial product release