Occasionally, applicants may disagree with an FDA decision regarding one of their submissions. A recent guidance published by the U.S. FDA..

Recently, the U.S. Food and Drug Administration released a guidance to explain how assessment goals are set for amendments to...

Countries often establish national medical stockpiles to prepare for public health crises and unexpected drug shortages...

Thanks to its push towards digitalizing business services, Estonia has become an attractive hub for entrepreneurs, IT professionals, and ...

One of the pharmaceutical industry’s top priorities is to ensure the safe use of medications without compromising their efficacy...

Estonia is an excellent example of how investment in innovation can drive economic and research growth. On average, 227 PhD degrees are...

The rising costs of U.S. healthcare affect all participants in the supply chain, from manufacturers to patients...

Comparing bids is a critical step since it affects the overall production cost and product margins. In our experience ...

This autumn, the U.S. Secretary of Health and Human Services (HHS) has finally begun negotiating prices for 10 Medicare Part D drugs as...

The growth of the generics market has produced impressive economic benefits for the United States. The Association for Accessible...

At The J. Molner Company, company values are not just a business buzzword. We define company values as tangible, measurable, and ...

Employees who feel engaged, motivated, and aligned with the values of their workplace are more likely to contribute to the success of ...

Summer is a season perfect for relaxation, as the Estonian tradition of “summer days” attests. Summer days are events organized...

Recent updates in FDA guidelines open a cost-saving opportunity for pharma companies looking to fulfill dermatological bioequivalence...

At The J. Molner Company, we have revamped our portfolio of services to support pharmaceutical companies navigating FDA reporting...