Proregulations news

Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical companies. The MAA is complicated by the need to consider both European economic integration and the independence of individual member states.

As a specialist in regulatory matters, Proregulati

The EU Active Substance Master File (ASMF) is a technical document containing confidential information on an API that is submitted by the manufacturer of the API to the EMA or the medicines regulatory authority of an EU member state. As a form of DMF in the EU, the ASMF is used to support MAA or MAV by manufacturers of pharmaceutical preparations for human or veterinary use.

The ASMF applies to applications for new active substances, pharmacopeial active substances (included in

U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that the product has the same safety and effectiveness in terms of intended use, design, materials, implementation standards, and other aspects as similar products that have been legally

An Abbreviated New Drug Application (ANDA) is an application submitted to the U.S. FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of safety, efficacy, and quality. The ANDA contains information used for the review and approval of a generic drug product, and does not typically require preclinical and clinical trial data, but rather requires the inclusion of information on bioequivalence to the RLD.

The FDA regulates cosmetics and their ingredients on the U.S. cosmetics market. Strict adherence to FDA regulations and standards is essential for the smooth entry and successful operation of cosmetic products on the US market. At Proregulations, a company that specializes in assisting with regulatory compliance, we offer U.S. Cosmetics Registration services designed to ensure that cosmetics meet U.S. regulat