Lessons Learned on Product Development and Regulatory Submissions
The FDA’s recent finalizations of Good Manufacturing Practices for Combination Products may have left you uncertain about changes in regulations. Strategic product development, implementation and execution, as well as the correct submission framework, can greatly increase the successful launch of your Combination Product. Learn more about this topic during this webinar on Combination Products: Lessons Learned on Product Development and Regulatory Submissions.
In this one-hour webinar, you will learn how to:
- Simplify the requirements and navigate complex regulations
- Establish product development strategy, and implement and execute development via requirements, V&V testing, and the Design History File (DHF)
- Prepare an effective regulatory submission to address potential challenges
- Incorporate lessons learned from challenging case studies
Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Regional offices in Florida, Colorado and Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021