FarmavitaR+ : Regulatory Affairs Network

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Embrace the eCTD and stay ahead

As one door closes, businesses must look for their next opening. Today, the traditional strongholds of the pharmaceutical industry, the US and Europe, are witnessing a downturn in growth to around 6% a year. This is the result not only of problems in the broader economy, but also the loss of marketing exclusivity by products in a number of major therapeutic categories; lower contributions from new products because of increased scrutiny of their value; and slower take-up by doctors and healthcare systems.

Intellectual Propriatery News

FDA Improves Generic Drug Access

FDA Announces Measures to Improve Generic Drug Access

The Food and Drug Administration (FDA) im March 2004 announced that it will provide more information to the public to help generic drug applicants determine if they are eligible for 180-day marketing exclusivity for their products. This period of marketing exclusivity is generally provided to the first generic drug that challenges a patent for the innovator product.

Events

Sales Force Effectiveness Europe

7th annual Sales Force Effectiveness Europe Conference for Pharma

Do you have all the knowledge and contacts you need to increase sales and meet targets in the ever-changing and turbulent healthcare environment? Built on 7 years of success, the Sales Force Effectiveness Conference Europe is the only event that sales and marketing strategy innovators and leaders in sales and marketing need attend in order to find out the latest trends, network with like-minded peers and discuss common challenges. In healthcare environment where payors and government are under increasing pressure to cut costs and reduce spending and with a global recession looming, the pharmaceutical industry is under increasing pressure to deliver more value to it's customers, with less resources AND provide shareholder value. An impossible conundrum you may think.

Market Report

Leading Drug Delivery Companies and Technologies

Leading Drug Delivery Companies and Technologies: Competitive landscape, company profiles and technological developments

Over the last decade, the drug delivery industry has evolved to become a key area in the development of value-added pharmaceutical products. The global market grew from $15bn to $40bn during 2000–2006 as companies increasingly turned to drug delivery technologies as a means of expanding product lifecycles, enhancing drug efficacy and maximizing revenues.

Life Science Article

CALONYCTION MURICATUM

A RARE HERB OF MADHYA PRADESH HAVING PIVOTAL IMPORTANCE IN FOLK REMEDIES

Kotlaiya is an important medicinal plant of the ancient system of healing. It is type of kantkāri, a medicinal plant widely used in Āyurveda in the treatment of respiratory diseases. It has been described as white variety of kantkārī. The present paper reviews the pharmacognosy, phytochemistry and traditional uses of the herb.

Product Report

Insulin antidiabetics

Insulin antidiabetics - Return to injections alternative delivery methods fall by the wayside

Alternative delivery methods under development have so far failed to live up to expectations. In many cases the technical difficulties associated with the delivery technique have not been overcome, leading to a return to injection based therapies. Big Pharma have all but exited the development of new insulin therapies leaving the field to small niche players.

Newsflash

Regulatory Affairs Support for EU and USA

In collaboration with Regulanet network of regulatory affairs consultants throughout Europe and USA, we keep daily contacts and communication with National Agencies for Medicines and Medical Devices. Beside regulatory we also maintain understanding of the business, scientific and technical background of products.