The global regulatory authority submission process – through all its phases – is smoother with a proven partner.
Precision execution. We invest in your submission’s success with our team of experienced regulatory leaders. Your submissions are backed by broad experience and specialized expertise in a wide range of therapeutic areas and indications.
Our submission services include:
- CTA / IND submission and maintenance throughout the program lifecycle
- NDA / MAA / product registration, submission and maintenance throughout the product lifecycle
- Import / export license application
- End-of-trial activities
Each market has its own unique hurdles. Working together, they’re easier to jump.
Our Global Regulatory Submissions team is your team too, advancing your regulatory authority filings in more than 55 countries whilst operating from the following countries:
- Americas: US, Canada, Argentina, Brazil, Chile, Colombia, Mexico and Peru
- Europe: Spain, Poland, France, Germany, Russia and the United Kingdom
- Asia-Pacific: China, Singapore, Japan, Taiwan and South Korea