By thinking ahead during the regulatory process, we are able to avoid unnecessary hurdles in the approvals process. We identify gaps, work through the right strategies for practical product application, and prepare for label claims.

• Provide guidance and evaluation on all regulatory strategy aspects
• Support development of biologics, biosimilars, repurposing, devices, and combination products
• Support Orphan Drugs Designation preparation and submission
• Advise on Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA, and 505(b)(2) submissions
• Provide short and long-term regulatory strategies for medical devices, IVDs, and combination products
• Conduct Due Diligence assessments