Resources

Preparing a Clinical Evaluation for a CE Mark is no small task. Having it rejected by reviewers, and doing it over again to correct deficiencies is not uncommon. Clinical evaluations...

In this episode of RCA Radio, host Brandon Miller is joined by Eric Januszewski, Senior Director of Client Relations for US and Europe, at Regulatory Compliance Associates (RCA) to talk...

Q: I am familiar with the term ALCOA as it relates to data integrity, but lately, I have heard people refer to ALCOA+. Can you explain what impact this new...

Essential insights are crucial for pharmaceutical technology executives dealing with the complexities of re-registration and labeling changes that arise from manufacturer or product name changes, which have become more frequent...

Whether you need support with New Product Development, Compliance Assurance, or help navigating a 483, Warning Letter, or Consent Decree, RCA can help. Download the complete list of our services...

It is no surprise that over the course of 2021 with the COVID-19 pandemic that businesses have adjusted their model to accommodate FDA audit remote work. Whether that be associates...