FDA CONSULTING SERVICES
As a leading provider of strategic sourcing and procurement consulting services for the medical industry, our company is committed to helping our clients to navigate the FDA regulatory landscape in the Africa Continental Free Trade Area (AFCFTA)
Our FDA Service is designed to assist medical manufacturers and suppliers in achieving compliance with all FDA requirements while also providing support in the event of a product recall or corrective action. With years of experience, AHL provides FDA consulting services across AFCFTA.
FDA REGISTRATIONS
Medical device manufacturers and suppliers are required to register with the FDA. Our team can assist with the registration process, including the preparation and submission of required documentation. We can also help to ensure that your registration is up-to-date, and that all necessary information is provided to the FDA in a timely manner.
FDA REGULATORY COMPLIANCE
Compliance with FDA requirements is essential for medical manufacturers, distributors, and suppliers. Our team of experts has extensive experience in interpreting and implementing FDA regulations. We provide guidance on Good Manufacturing Practices (GMPs), Product Labelling and Packaging). We assist in the development and implementation of quality management systems (QMS) that are compliant with FDA requirements.
PRODUCT RECALL
Product recalls can be costly and damaging to a company's reputation. We are experienced in managing FDA-regulated product recalls and can help you to minimize the impact of a recall on your business. We can assist with the development of recall plans, the coordination of recall activities, and the communication of recall information to the public and to the FDA
Request For FDA ServiceFDA LETTERS RESPONSE
Receiving a letter from the FDA can be very intimidating, we take the burden from your hands and respond to FDA. This service involves providing guidance and assistance to clients in responding to letters or communications received from the FDA regarding their products or business practices. This could include helping clients to understand and address any regulatory concerns or issues raised by the FDA, as well as drafting and submitting written responses to the FDA on behalf of the client
FDA REPRESENTATION & LEGAL DEFENSE
We provide legal representation and defense to clients in cases where they are facing enforcement actions or legal proceedings brought by the FDA. Our professionals represent clients in administrative or judicial proceedings, such as formal hearings or court cases, as well as providing guidance and assistance in negotiating settlements or other resolutions to disputes with the FDA.
CORRECTIVE ACTIONS RESPONSE
FDA may require a manufacturer or supplier to take corrective actions if a product is found to be noncompliant or if there is a problem with the manufacturing process. Our team will assist you with the development and implementation of corrective action plans. With our consulting service you can be assure that all necessary steps are taken to address the problem and prevent it from recurring in the future.