Regulatory Consulting and Strategic Intelligence Services
Our regulatory consulting and intelligence team is comprised of senior pharmaceutical regulatory experts with extensive experience in product development, preparation of global registration strategies and successful registration of products with regulatory authorities worldwide.
The team develops and manages product- and indication-specific global regulatory strategies that enable the most efficient registration pathway(s) and yield a high probability of approval success. Our consultants draw upon their extensive internal regulatory affairs knowledge and expertise in preclinical; chemistry, manufacturing and controls (CMC); and clinical and commercial development to build strategies that meet the demands of a dynamic regulatory environment.
Comprehensive global regulatory intelligence and therapeutic expertise
Leveraging our global presence, we access, summarize and assess global regulatory intelligence to ensure submissions are compliant with regional and local requirements. Our consultants provide ongoing surveillance of regional and local regulations, directives, guidelines and regulatory precedents to ensure creativity and rigor in product development and registration planning. This enables us to deliver sound regulatory strategies based on current regional guidelines in a global regulatory context.
Our regulatory intelligence professionals survey the competitive landscape for both developmental and approved therapies, while utilizing competitive gap analysis techniques to provide regulatory intelligence that supports product benchmarking.
Worldwide reach for proactive regulatory affairs strategies
Our global reach and active regulatory agency network provide local coverage in most key markets, enabling us to apply up-to-date, robust regulatory intelligence to product development and registration strategies. Our regulatory affairs group develops preemptive solutions for potential regulatory hurdles and ensures the quality of submissions to worldwide agencies to maximize the likelihood of successful review.
Global nonclinical regulatory services
Our nonclinical regulatory consultants provide specialized consulting to enable product development and lifecycle management. Nonclinical development scientists include American Board of Toxicology certified toxicologists and European Registered Toxicologists who have experience with a variety of compound types (small molecules and biologics), molecular targets, routes of administration and therapeutic areas.
Expert guidance on a broad range of pharmaceuticals
Our global regulatory affairs group includes scientists and experienced regulatory professionals with the broad global and regional regulatory knowledge needed to effectively facilitate communication with regulatory agencies and anticipate and resolve potential challenges. Each team member works in collaboration with colleagues from our clinical and product development departments, ensuring efficiency at every stage.
We offer a complete spectrum of comprehensive regulatory consulting and intelligence services including:
- Clinical trial applications
- Marketing applications
- Medical devices
- Medical writing
- Publishing and submissions
- Lifecycle management
- Preclinical and CMC consulting
- Agency interactions
- Strategic consulting and intelligence
- Quality review