Ensure safe and FDA-compliant drug products with our cost-effective, professional services—designed for both U.S. and international drug manufacturers. Let us simplify your path to regulatory approval!
Register with FDA
Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations is crucial for drug establishments aiming to bring safe and effective products to market. At Consult CertPRO, we offer professional and affordable services tailored to meet the needs of both U.S. and international drug companies.
With over two decades of experience, we assist drug companies in navigating complex compliance landscapes, allowing you to focus on your core business operations. Our services include:
We provide support for annual FDA Establishment Registration and commercial drug product listings, assist in obtaining DUNS numbers, and offer U.S. Agent representation to promote consumer safety.
Our team prepares DMFs in electronic common technical document (eCTD) format, ensuring secure sharing of proprietary product information. We can submit these files to 18 regulatory bodies worldwide, including the FDA and the National Medical Products Administration (NMPA) in China.
To comply with stringent drug labeling requirements, our regulatory specialists conduct thorough reviews of product labeling, assets, and ingredients. We provide detailed reports of our findings along with current regulatory details to facilitate compliance.
We offer professional support in addressing Import Alerts and Detentions without Physical Examination (DWPEs) by developing corrective action plans, documenting compliance across shipments, and submitting comprehensive petitions for removal.
If your shipment has been detained by the FDA for potential noncompliance, our team can assist in submitting a Testimony of Admissibility or reconditioning proposal to address the issues promptly.
We offer online, self-paced training programs designed for busy professionals to help you meet industry and regulatory requirements for pharmaceutical and over-the-counter products.
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold drugs intended for human or animal consumption in the U.S. must register their facilities with the FDA, unless exempt under specific regulations. This requirement applies to domestic facilities regardless of whether their products enter interstate commerce.
Certain facilities may be exempt from FDA registration; however, specific exemptions depend on various factors outlined in the Code of Federal Regulations. It's essential to consult with regulatory experts to determine if your facility qualifies for an exemption.
At Consult CertPRO, we are committed to guiding you through the complexities of FDA regulations, ensuring your drug products comply with all necessary requirements for successful market entry and distribution.