FDA Compliance Consulting

The FDA (Food and Drug Administration) ensures that your goods meet rigorous safety and quality benchmarks, not just locally but internationally too.

For the international manufacturers, with FDA compliance, you unlock access to lucrative markets like the USA, enhancing your brand's credibility and boosting sales.

Don't let regulatory hurdles hold you back. Embrace FDA standards and watch your business soar to new heights!

Contact the New Design Lab today and pave the way for your products to shine on the global stage!

Regulatory Strategy & Compliance

FDA regulatory assessments and gap analysis
Pre-market regulatory strategy development
Compliance audits and risk assessments
Labeling and marketing compliance

FDA Submissions & Approvals

New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)
Investigational New Drug (IND) applications
Premarket Approval (PMA) and 510(k) submissions for medical devices
Biologics License Applications (BLA)
Generally Recognized as Safe (GRAS) and New Dietary Ingredient (NDI) notifications
Food Facility Registration (FFR) and compliance with FSMA requirements

Quality Systems & Good Manufacturing Practices (GMPs)

Implementation and auditing of GMPs for pharmaceuticals, medical devices, and food products
Quality system development and remediation
Standard Operating Procedures (SOPs) development and training

Clinical & Nonclinical Support

Clinical trial design and regulatory oversight
Institutional Review Board (IRB) and FDA interaction support
Nonclinical study compliance and safety assessments

Custom Regulatory Solutions

Every company has unique challenges. We offer tailored solutions to meet your specific regulatory needs, ensuring compliance while optimizing time and cost efficiency.

Why Choose Us?

Industry Expertise: Decades of experience in FDA regulatory affairs.
End-to-End Support: From initial strategy to post-market compliance.
Regulatory Success: Proven track record of FDA approvals and successful compliance audits.

FDA Inspections & Post-Market Compliance

FDA inspection readiness and response strategies
Corrective and Preventive Actions (CAPA) support
Adverse event reporting and pharmacovigilance
Post-market surveillance and recalls management