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Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development
Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track
Biosimilars: How the Approval Process Differs from a Standard ANDA
Biosimilars, by their very nature, are different from generic drugs. The core difference is that generic drugs are chemically synthesized, while biosimilars are grown in complex living systems....
Why It's Smarter to Play the Long Game When Planning Your FDA Submission
The drug development process is long and expensive. You are doing yourself and your product a huge advantage if you enter and go through the process with a well-researched plan. When planning your...
6 Ways to Increase the Value of Your Cell and Gene Therapy or ATMP Development
As the field of modern medicine is changing, so should the development strategies of these new therapies such as cell and gene therapy (CAGT) products, also known as advanced therapy medicinal...
How to Ensure Your Device, Software, and Drug Are All Ready for a Pre-Approval Inspection
When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a...
EMA vs. FDA Virtual GCP Auditing Guidance: What You Need to Know
In response to the COVID-19 pandemic, global regulatory authorities adopted a pragmatic virtual auditing approach. This approach includes the flexibility and procedural simplifications to maintain...
Preventive vaccines are a special kind of medicinal product, as they are administered before a disease instead of during. You are probably familiar with preventive vaccines from your own or your...
505(b)(1) vs. 505(b)(2): Choosing the Appropriate Regulatory Pathway
Because the FDA is an agency established by a federal law, there are clearly defined pathways along which a drug can be approved. Deciding on the appropriate regulatory pathway for your drug...
The FDA has a strong interest in promoting the health and safety of U.S. citizens; in addition, it also supports the advancement of the global harmonization of regulatory requirements and practices....
How quickly the auditing landscape has changed! Less than one year ago if ProPharma Group were asked to perform a clinical audit on your firm’s behalf, we would reply with “when, what, and where?”...
