thought leadership

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.

Meet the Expert Medical Information

October 5, 2023

Meet the Expert: Pinky Sharma

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

FDA Regulatory Sciences

September 29, 2023

Navigating FDA User Fee Updates for Fiscal Year 2023

As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...

FDA Regulatory Sciences

September 27, 2023

The Impact of a US Government Shutdown on the Food and Drug Administration

U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

Quality & Compliance Medical Information

September 25, 2023

DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

Meet the Expert Medical Information

September 21, 2023

Meet the Expert: Kamila Rocha

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

FDA Guidance Regulatory Sciences

September 20, 2023

Clinical Pharmacology Considerations for Peptide Drug Products, September 2023

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall...

Meet the Expert Regulatory Sciences

September 14, 2023

Meet the Expert: Shauna Burns

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Clinical Research Solutions Clinical Trials Registration

September 12, 2023

Frequently Asked Questions About Clinical Trials Registration and Disclosure

In the ever-evolving landscape of clinical trials disclosure, navigating the intricacies of registration, compliance, and ethical transparency has become more crucial than ever. Pharmaceutical and...

Regulatory Sciences Market Access

September 7, 2023

Navigating Market Access & Reimbursement Strategy for Medical Products

Developing in vitro diagnostic tests, laboratory-developed tests, medical devices, or therapeutics is complex and requires careful consideration of various factors. One critical aspect that often...

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