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The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products.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...
EMA
Clinical Research Solutions
September 5, 2023
EMA Policy 0070: Back on the Road to Transparency
By now, most involved in the clinical trials disclosures field are aware of the upcoming reinstatement of the European Medicine Agency's (EMA) landmark transparency regulation: Policy 0070. Policy...
Biotech Startup
August 31, 2023
Top 10 Best Practices for Successfully Obtaining Second Round of Funding for Biotech Startups
Securing funding is a crucial milestone for biotech startups aiming to advance their research and bring innovative products to market. Once the initial round of funding is secured, the next challenge...
Regulatory Sciences
August 30, 2023
A Closer Look at FDA's Nitrosamine Impurity Regulations for NDSRIs
FDA Provides Acceptable Intake Limits for Nitrosamines Drug-Substance Related Impurities (NDSRIs). Can You Comply? The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled;...
Biotech Startup
August 24, 2023
Biotech Start Up: How to Transition from Early Phase Biotech to Late-Stage Biotech
Biotech startups face a number of challenges as they progress through the various stages of drug development. While early-stage biotechs focus on developing and testing their products, late-stage...