How do you prepare for an unannounced audit from a Notified Body or the FDA?
Few phrases make quality teams more anxious than “unannounced audit.” Whether it’s a Notified Body conducting a surprise visit under the EU MDR/IVDR or an FDA investigator arriving unannounced for an inspection, these audits test your organization’s true level of...
What are the benefits of eQMS vs. paper-based systems for small manufacturers?
For many small and growing life science manufacturers, managing quality can feel like a balancing act. On one hand, regulatory compliance is non-negotiable. On the other, budgets and staffing are often limited. Traditionally, companies have relied on paper-based...
How do you navigate regulatory submissions for ATMPs (gene and cell therapies)?
Gene and cell therapies, collectively known as Advanced Therapy Medicinal Products (ATMPs), represent one of the most exciting and challenging frontiers in modern medicine. These therapies have the potential to treat, and even cure, diseases once considered...
What are the most common reasons regulatory submissions are delayed or rejected?
Submitting a regulatory application, whether to the FDA, EMA, or another health authority, represents years of research, validation, and investment. Yet, even well-prepared companies experience delays, rejections, or major questions during the review process....
What Are the Differences Between FDA, EMA, and PMDA Approval Pathways?
Bringing a new drug or biologic to market is a long and highly regulated process — and each major region has its own regulatory authority and approval pathway. In the United States, the FDA oversees product approval. In Europe, it’s the EMA, and in Japan, it’s the...
How Do You Manage Safety Reporting and Pharmacovigilance?
In the life sciences industry, patient safety is non-negotiable. Whether you’re developing pharmaceuticals, biologics, or medical devices, establishing a robust pharmacovigilance (PV) and safety reporting system is critical to compliance, product integrity, and public...