All services are provided with the utmost concern for high quality and customer expectations.
These services include, but are not limited to the following:
Preparation for and participation in regulatory agencies meetings
planning and risk assessment for CMC regulatory submissions
New Drug (IND) Applications
Clinical Trial Applications (CTAs)
US New Drug Applications
US Abbreviated New Drug Applications (ANDA)
EU Marketing Authorization
New Animal Drug Applications (NADAs)
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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