ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Clinical Research Solutions
Job Description The Weinberg Group, the leading FDA consultancy, is growing and looking for regulatory professionals of all levels to join our staff. Successful candidates will have at least a...
Clinical Research Solutions
Job Description Great opportunity for someone looking to launch their career in the sales or administrative fields! Prior experience is not required, but may be helpful. The Weinberg Group, the...
Clinical Research Solutions
Job Description The Weinberg Group, the leading FDA consultancy, is expanding and seeking an experienced CMC professional to add to our existing capabilities. Qualified candidates must have at least...
Clinical Research Solutions
The Food and Drug Administration Safety and Innovation Act (FDASIA), was signed into law on July 9, 2012. This law significantly expanded the FDA’s authority and strengthened its ability to safeguard...
Clinical Research Solutions
If you’ve spent a reasonable amount of time in an FDA-regulated industry, you’ve most likely been part of an FDA inspection. Should you be more fortunate, you have participated directly with the...
Clinical Research Solutions
Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...
Clinical Research Solutions
Over the past several years, outsourcing within the pharmaceutical supply chain has become common. The rise of the “virtual” pharmaceutical company has resulted in a complex supply chain, with the...
Clinical Research Solutions
On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a...
Clinical Research Solutions
What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...
Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...