Pharma ACTD Dossiers

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...

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...

       Future of pharma outsourcing The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales; total sales reached US$773 billion in 2008, according to IMS Health. Annual growth in the European Union (EU) has slowed to 5.8%, and sales are increasing at an even more sluggish rate in Japan (2.1%) and North America (1.4%).1 Impending policy changes, promoting the use of generics in these key markets are expected to further dent the top- and bottom-line of global pharma majors. The industry is bracing itself for some fundamental changes in the marketplace and is looking at newer ways to drive growth. More than that, India has a growing pharmaceutical industry of its own. It is likely to become a competitor of global pharma in some key areas, and a potential partner in others. India has considerable manufacturing expertise; Indian companies are among the wor...

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...

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...

Indian Regulatory system                               Overview                                        Pharma ACTD Dossiers Introduction Geographically, India is comprise area of 3.29 million sq. km. (1.27 million sq. mi.); about one-third the size of the USA. Genetically, culturally and socio-economicallydiverse population base of more than 1.2 billion is a home for a numerous diseases as well as for qualified, English-speaking professionals, Institutions and hub of contract manufacturers and researchers. Today, Indian economy stand as the third largest based on the Purchasing Power Parity (PPP) and in terms of globally eleventh largest by nominal Gross Domestic Product (GDP), due to its rapid growth, especially over the last decade, India is considered an industrialized  nation. Apart from bein...