Catalyst Regulatory Services, LLC provides Regulatory support to pharmaceutical companies, ranging from start-up to large multiple-national corporations. Catalyst was founded and is led by an industry veteran, with over 25 years of pharmaceutical Regulatory Affairs experience.
Our business model is to provide Regulatory staff that can “hit the ground running” and work with little supervision, based upon our extensive experience.
- Aligning Regulatory Strategy to Productive Objectives
Understanding the regulatory strategy for an exploratory product is a critical success factor in its development. Catalyst Regulatory Services’ staff can assist clients in analyzing key regulatory issues and navigating the complex path through development. These aspects include timing for regulatory authority engagement, the changing external regulatory environment, possible options for accelerating development and additional data exclusivity.
The regulatory team at Catalyst Regulatory Services provides regulatory leadership to development teams, working in collaborative team environments at all stages of the project life cycle. We have detailed experience in regulatory due diligence to support decision making on licensing and investment opportunities. We also have the experience to provide expert input on a variety of regulatory topics such as QT prolongation, abuse liability, pediatric drug development and assessment of suicidality.
- Quality Regulatory Authority Interactions
Through experience of countless regulatory authority interactions, the Catalyst Regulatory Services’ staff each has a detailed understanding of building and maintaining effective relationships with regulatory agency staff at all levels. These relationships can help a company navigate a clear path through the daunting regulatory maze.
We have participated in hundreds of regulatory authority liaison activities and have the knowledge and expertise to prepare clients for critical agency interactions. Our experience includes leadership at FDA Pre-IND, End of Phase 2, and Pre-NDA meetings, Label negotiations, FDA Advisory Committees and European national regulatory interactions and CHMP meetings.
- Value-Added Regulatory Submissions
The Catalyst Regulatory Services’ team has made hundreds of submissions to regulatory authorities, ranging from routine IND updates to full-blown marketing applications in the US and EU. We understand the vital importance of high-quality documentation and the value of a customer-focused approach to regulatory applications.
For optimal security and compliance, Catalyst Regulatory Services has the infrastructure to provide electronic document management and the processes to ensure clear communication between regulator and client.