All services are provided with the utmost concern for high quality and customer expectations.
These services include, but are not limited to the following:
Regulatory Project
Management Preparation for and participation in regulatory agencies meetings Strategic
planning and risk assessment for CMC regulatory submissions Document Preparation Investigational
New Drug (IND) Applications Clinical Trial Applications (CTAs) US New Drug Applications
(NDAs) US Abbreviated New Drug Applications (ANDA) EU Marketing Authorization
Applications (MAAs) New Animal Drug Applications (NADAs) Rest-of-World
applications Responses to Regulatory Agency inquiries
- Comprehensive review of all types of CMC regulatory documents
- Assistance in data analysis
for establishing registration specifications
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