Consulting Services

Strategic Regulatory Support

• Short and long term regulatory strategy.
• Gap assessments and guidance at any stage of development.
• Due diligence assessments.
• Analytical and clinical study design and review.

FDA Submission Support

• Prepare or assist in the preparation of all types of regulatory submissions including EUA, Pre-Submissions ,510(k)s, PMAs, IDEs, de novo, HDEs, RFDs, 513(g)s, pre-IND, IND, BLA.
• Technical review and guidance of supportive documentation for submission.
• Comprehensive "FDA style" review of submissions.
• Strategy and assistance with responding to FDA requests for additional information.

Quality System Support

• Assist with Quality System documentation development.
• Perform mock audits in preparation of FDA pre-approval inspection and/or bi-annual quality inspection.
• Provide customer specific topic training on FDA regulatory issues and new policy developments.
• Provide assistance in overseeing manufacturing and quality control.
• Establishment registration and product listing.