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Showing posts from June, 2018

Regulatory Affairs

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 (pharmaceuticals, 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 Securities and Exchange Commission (banking). ·Advising their …

Product list updated

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

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 CommissionDCP 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. The subsequent steps a…
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 Universiteit Bruss…