Resource Library

In life sciences, trust defines success. Patients, regulators, and partners rely on companies to develop safe and effective products with complete transparency.

The most effective regulatory compliance software creates visibility across departments, ensuring that every record aligns with GxP and ISO expectations, and making inspection readiness a...

In life sciences, regulatory compliance is the foundation that protects patients, ensures product safety, and maintains the integrity of every organization in the field.

Whether developing...

Compliance failures are rarely the result of a single mistake. They’re usually the product of small, preventable issues that snowball over time: a data field left incomplete during clinical...

Bringing a new therapy to market in the European Union requires years of work across research, development, and compliance.

For medical device manufacturers, the Premarket Approval (PMA) process is the most rigorous path to market in the United States. Reserved for Class III devices that sustain life, prevent...

A Biologics License Application (BLA) is one of the most critical milestones in the development of a biologic therapy. It is the formal request submitted to the U.S. Food and Drug...

Generic drugs play a critical role in improving patient access and reducing healthcare costs. But bringing a generic to market is not a simple process. Companies must demonstrate that their...

The goal of an NDA application is to present a clear, defensible story across CMC, nonclinical, clinical, and labeling so reviewers can evaluate benefit and risk without searching for...

If you’re developing a new medical device and there’s no clear predicate on the market, you may be wondering whether the FDA’s De Novo pathway is the right route forward. The process can...

Launching a clinical trial outside the United States requires more than a strong protocol. It requires regulatory approval in the form of a Clinical Trial Application (CTA).

Life sciences companies face some of the strictest regulatory environments in the world. From FDA and EMA oversight to global standards like ISO 13485 and GDPR, compliance requirements...