Broad Experience, Deep Expertise
To ensure your success, you need a partner who has local and global experience to understand your specific requirements and how to optimize and execute your drug or medical device development program.
We have completed over 1,500 local and global contract research and regulatory projects.
In addition, our global regulatory & strategic development (RSD) consultancy has completed 300+ engagements and has deep expertise working with clients developing products in Dermatology, Pain, Ophthalmology, Rheumatology, Oncology, Infectious Disease, Vaccines, and other cell and tissue based therapies.
Additionally, we have extensive experience with regulatory submissions to all major authorities, including:
- 200+ Agency meetings
- 400+ CTA applications worldwide
- 65+ IND original applications and major amendments
- 30+ major submissions for marketed products
- 10+ compete NDA or BLA original applications, including eCTD format
Simply click on the therapeutic category to see our comprehensive experience, or click the phase tab to learn more about our experience by phase.
- Central Nervous System
- Eye, Ear, & Respiratory
- Infectious Diseases
- Ob/Gyn& Urology
- 9Central Nervous System
- 7Eye, Ear, & Respiratory
- 13Infectious Diseases
- 4Ob/Gyn& Urology