Pharma ACTD Dossiers

Regulatory affairs Regulatory affairs  ( RA ), also called  government affairs , is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries ( p harmaceuticals ,  medical devices ,  biologics  and  functional foods ). Regulatory affairs  (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas: ·          Ensuring that their companies comply with all of the regulations and laws pertaining to their business. ·          Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the  Food and Drug Administration  or  European Medicines Agency  (pharmaceuticals and medical devices); The Department of Energy; or the Se

Product List Pharma ACTD dossiers is the leading company in pharma regulatory pocesses.At start we were having about 150-200 products but as we are growing now the list has increased to 1000+ products. All the documents of the products in the product list are updated and are ready to use. please see our  product list Dossiers Our  dossiers  are compositions of the data most crucial in gaining a strong foothold in a subject area. We compile our  dossiers  in accordance with the most recent researches and according to client's requirements. These  dossiers  contain links to the most important information about a certain topic, they are not exhaustive lists of everything that has appeared online. We undertake the full project i.e after careful market survey we select products of priority for registration and also provide complete regulatory support till the registration stage Company registration in getting brand search and registered wherever mandatory. Prepar

Drug approval process in European countries        CP Centralised Procedure Marketing authorisations granted under the "centralised procedure" allow the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation . Under the centralised procedure, a company may only obtain one marketing authorisation per medicinal product. However, in specific cases a company may apply for a duplicate marketing authorisation. Requests to submit an application for a duplicate should be sent to the Commission   DCP Decentralised Procedure An identical application for marketing authorisation is submitted simultaneously to the competent authorities of the Reference Member State and of the Concerned Member States. At the end of the procedure, the draft assessment report, SPC, labelling and package leaflet, as proposed by the Reference Member State, are approved.

Europe’s new data protection rules Europe wants to conquer the world all over again. Only this time, its killer app isn’t steel or gunpowder. It’s an EU legal juggernaut aimed at imposing ever tougher privacy rules on governments and companies from San Francisco to Seoul. When the region’s regulators roll out the changes — known as the General Data Protection Regulation, or GDPR — on May 25, it will represent the biggest overhaul of the world’s privacy rules in more than 20 years. The new regulations offer EU citizens sweeping new powers over how their data can be collected, used and stored, presenting global leaders outside the 28-country block with a stark choice: bring their domestic laws in line with the EU’s new rules, or risk being shut out of a market of 500 million well-heeled consumers. “Data protection is a good example of Europe trying to extend its influence over other countries,” said Christopher Kuner, co-chair of the Brussels Privacy Hub at the Vrije