Pharma ACTD Dossiers

👽REGULATORY BODIES👽 A R egulatory Body    (also  regulatory authority ,  regulatory  agency  or  regulator ) is a  public authority  or  government agency  responsible for exercising autonomous authority over some area of human activity in a  regulatory  or supervisory capacity. An independent regulatory agency is a regulatory agency that is independent from other branches or arms of the government. Regulatory authorities are commonly set up to enforce safety and standards, and/or to protect consumers in markets where there is a lack of effective competition or the potential for the undue exercise of market power. Examples of regulatory agencies that enforce standards include the  Food and Drug Administration  in the United States and the  Medicines and He...

What Is The Registration Process For Exporting A Drug In Different Countries? Exporting drugs to different countries depends on the regulatory system of the both the courtiers. Import and export of drugs from a pharmaceutical industry are allowed after gaining all the approvals. Earlier in India, the export of drug was not a cumbersome process but, now the Indian regulatory system is too fragile. It takes about a year or so for a drug to be approved for marketing. The ever-changing laws, regulations, and demand have completely tossed the approval process. The Central Drugs Standard Control Organisation of India controls the import and export of pharmaceutical products. Drug Registration Process Drug registration is a system meant for all the pharmaceutical products. It is required for pre-marketing evaluation, marketing authorization, and post-marketing review so as to ensure that all the products fall in the standards of quality, safety, and efficiency. In short, drug reg...

South Africans need to return 318,000 packets of potentially dangerous pills The South African distributor of heart pills that may contain a potentially carcinogenic ingredient has confirmed that more than 318,000 packets of pills may be affected. “Operationally, it is a difficult situation,” a representative of Pharma Dynamics, the distributor of the tablets in South Africa, told Business Insider South Africa. The South African Health Products Regulatory Authority (SAHPRA) this week recalled Dynaval Co high blood pressure and heart pills, which may contain a controversial carcinogenic ingredient that was manufactured in China. Dynaval Co 80/12.5 mg, 160/12.5 mg and 160/25 mg pills, which were manufactured by Zhejiang Huahai Pharmaceuticals, may contain the chemical NDMA. NDMA is associated with liver damage and liver cancer in rats as part of laboratory tests, says dr Eric Decloedt, a clinical pharmacologist at the department of medicine of the University of St...

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent. Good documentation practice  (commonly abbreviated  GDP , recommended to abbreviate as  GDocP  to distinguish from "good  distribution  practice" also abbreviated GDP) is a term in the  pharmaceutical and medical device industries  to describe standards by which  documents  are created and maintained. What to write, and how to GDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FD...

GMP- GOOD MANUFACTURING PRACTICES Good manufacturing practices  ( GMP ) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of  food  and  beverages ,   cosmetics ,   pharmaceutical products ,  dietary supplements,  and  medical devices . All guideline follows a few basic principles: Manufacturing facilities must maintain a clean and hygienic manufacturing area. Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use. Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes must be controlled, and any changes to the pro...

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 register...

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,...

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,”...