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 ...

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...

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 Ad...

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...