Regulatory Compliance Associates Inc. helps navigate the constantly changing domestic and international regulations to successfully register your medical devices, IVDs, biologics, and pharmaceuticals.

• • Determining whether registration is required
• • Regulatory Strategy (drug and medical devices)
• • Domestic and international establishment registration
• • Product classification
• • Technical writing [510(k) submissions, PMA submissions, de Novo, New Drug Applications, Generic Drug Applications, Drug Master Files (all types), Technical Files, Clinical Reviews, Explanation letters, etc.]
• • Creating Submission Packages
• • Follow-up and question resolution
• • Audit support