adminipi

Examining the Latest Regulatory Updates and Best Strategies for Product Registration in Moldova, Uzbekistan, Georgia and Azerbaijan

Dec 17, 2018

In recent years there has been significant growth in the pharmaceutical industry of CIS countries like Azerbaijan, Uzbekistan, Moldova and Georgia. In this article, Pelin Boran at Pelin Boran Regulatory Affairs Solutions & Consultancy reveals some practical notes on the registration process in these countries, the content required for MA applications for pharmaceutical products, and some regulatory notes for guidance. ...

Read More

Regulatory Overview on Irrational Use of Fixed Dose Combination in India Comparison with USA and EU

Dec 17, 2018

The road towards product development and regulatory approval is long, arduous and costly. Thus, to recoup the money invested in the drug and make it profitable, manufacturers are combining drugs to make fixed dose combinations and entering them into the NDA list, thus giving them huge profit and demand. Balamuralidhara V, Raghunandan H.V. and Suresha M. at JSS College of Pharmacy argue that this leads to long-term presence of the product in the market at the cost of the health and safety of patients. ...

Read More

Regulatory Submissions: Taming the Beast

Dec 17, 2018

Regulatory activity in the life sciences world is extremely variable, so historically, attempts to measure output have been too simplistic to be effective. When the work was managed internally and companies’ budgets were ample, this didn’t matter too much – because if loads increased, companies could simply add more staff as needed. Adrian Leibert at Kinapse explains that as regulatory workloads soar, the first step to better resource management is better measurement. ...

Read More

Partners in Evolution; What Does the Future Hold for Drug Delivery Devices

Dec 17, 2018

There are exciting and interesting trends emerging. Therapies once only feasible within a clinical setting are now being self-administered at home, enabled by innovations in delivery technologies. Established platforms are being refined and continually improved. Patient preferences for devices can now be a market reality while remaining commercially viable. John Burke at Team Consulting analyses if the device in conjunction with the therapy is essential to ensure potential pitfalls are avoided, and the device is an enabler rather than a barrier to market success. ...

Read More