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Regulatory Services – US & EU
Our regulatory team has the expertise to develop strategic regulatory plans, facilitate Agency meetings, and prepare, review, and file regulatory submissions in both the US and across Europe.

 

Regulatory Affairs and Compliance

Quality Assurance

Auditing and Quality Management

 

 

CMC Technical Support

SOP Development and Review

Site Inspections

 

 

Utilize Actua Software for full electronic regulatory submissions internally

Supply Chain Management

Licensing

 

 

Regulatory Services US & EU