Quality + Safety + Transparency
We deliver quality in every aspect of our work, across all systems and teams and this translates into superior support for your product’s regulatory requirements.
We are committed to regulatory excellence – our experience across numerous regulatory pathways and requirements provides you with a partner that supports and understands your regulatory challenges.
- Product Development Strategy
- Master File Development
- Investigational New Drug (IND) Applications
- Pre-Clinical Study Design
- Chemistry, Manufacturing and Controls (CMC) Development
- Biological License Applications (BLA)
- Medical Device 501(k)
- Preparation/Representation at Regulatory Meetings
- Regulatory Submissions, Amendments, Supplements & Reports
Looking for expert solutions in Regulatory Support?
We’re a reliable, experienced and adaptive partner focused on quality and adherence to regulations. Let’s talk about your next challenge together.