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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, Proregulations has ...
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 ...
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, ...
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 ...
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 ...
The Korea Health Industry Development Institute (KHIDI) announced on the 31st that it held the 'China Pharmaceutical Bio Investment Briefing (IR)' on the 20th, where domestic pharmaceutical companies introduced their technologies to Chinese investors. This event was jointly held with the Shanghai office of NH Investment & Securities. 10 domestic companies made IR presentations. KISA is ...
MicrobioSeq represents the microbial genomics division of CD Genomics, headquartered in New York, USA. CD Genomics is a genomics service company with a good reputation for providing reliable sequencing, genotyping, microarray, and bioinformatics services. To help scientific researchers better understand fungal biodiversity, physiology, metabolism and function, CD Genomics MicrobioSeq has launched ...
Nuritas, a biotechnology company revolutionizing the discovery and development of plant-based bioactive peptides, has closed a $45 million USD Series B funding round. The investment, led by Chicago-based Cleveland Avenue, LLC, includes Grosvenor’s Wheatsheaf Group, the European Circular Bioeconomy Fund (ECBF), Singapore-based Vertex Holdings, Nutresa Ventures/ Veronorte and CJ. Cultivian ...
BEIJING, CHINA (April 20,2021) -" Green Innovation and Sustainable Solutions" was the key theme of the first edition of Asia Wipes Summit held in Shanghai, China April 1 -2,2021. The leading conference jointly organized by China Nonwovens & Industrial Textiles Association (CNITA) and E.J. Krause & Associates, Inc. (EJK) in the wipes industry brought together 350 participants from the ...
An exclusive and limited offer is presently being offered to clinics interested in offering treatment. Demo proposal is for a three month period and incorporates minimum 10 patient treatments, of 10 short sessions in 5 days, and follow-up p/p. Micro is the latest MoreNova model, offering patented Large Area Shockwave Technology for treating medical and cosmetic conditions. A small, light and ...
On June 18, 2014, Denmark’s order concerning a nano products register entered into force. The order imposes annual reporting requirements on manufacturers and importers concerning mixtures and products containing nanomaterials. The reporting requirements apply to mixtures and articles that are intended for sale to the general public and contain nanomaterials, where the nanomaterial itself ...
Health Canada began a public consultation on its adoption of the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials (Interim Policy). Although Health Canada is accepting comments, it states that the Interim Policy 'is effective immediately.' In preparing the Interim Policy, Health Canada states that it sought the informal feedback of some international stakeholders, ...