Pharma ACTD Dossiers

Pharmaceutical (drug and biologic) and medical device companies today are challenged with a stringent and continually evolving regulatory environment, together with changing technologies and global economic considerations. Regulatory Affairs is a very important part of regulated industries that manufacture products intended for human use. One such and also the most important is the pharmaceutical industry. Any product cannot enter the market unless and until it is authorized by the concerned regulatory authority. In 1937, Elixir Sulfanilamide which was marketed without any marketing testing caused deaths of more than 100 people in the USA. The pharmaceutical company added DEG as a solvent along with raspberry flavor for Sulfanilamide to be used as an elixir. This created an outrage and finally, led to the Federal Food, Drug and Cosmetic Act in 1938. However, the tragic incidents did not end there, there were many which led to various acts and amendments and one of the impactful ...

In general,  compliance  means conforming to a rule, such as a specification,  policy , standard or law.  Regulatory compliance  describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations. Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls. This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources. Regulations and accrediting organizations vary among fields, with examples such as PCI-DSS and GLBA in the financial industry, FISMA for U.S. federal agencies, HACCP for the food and beverage industry, and the Joint Commission and HIP...

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...

Pharma regulatory intelligence Less complexity. More clarity. Regulatory intelligence refers to the process of gathering, monitoring and analyzing regulatory information and data to track developments in the changing regulatory environment. Banking, financial services, and insurance sectors continue to experience unprecedented volumes of regulatory change and complexity. Our unique one-stop Regulatory Intelligence provides world-class content and advanced technology that cuts through the complexity and the sheer volume of content and developments within the regulatory compliance environment. That’s how we can provide clarity on what is most important to your organization –  in a cost effective way. Unsurpassed breadth, depth and quality Regulatory Intelligence includes global coverage of over 900 regulatory bodies and more than 2,500 collections of regulatory and legislative materials. It is powered by exclusive news, analysis, and practical guidance from...

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,”...