3-D Process™
 

 
Documentation
 

 
Marketing
 

 
Training &
Development
 

 
Regulatory & Compliance
 

 
Translation
 

The compliance experts at Tim Rosa Associates can work with your pharmaceutical, biotechnology, medical devices, technology, or financial services company to help you to develop documentation that demonstrates compliance with global regulatory authorities.

We collaborate with you using a predictable, reliable, and integrated process that

• Engages your key stakeholders across business units
• Interprets regulations in the context of your business
• Fully leverages the knowledge and experience of your in-house staff
• Reviews your current documents and best practices to identify gaps and make recommendations
• Calls on commercial software to create templates and final deliverables

We are experienced at creating documents that satisfy such stringent requirements as

• 21 CFR Part 11
• Sarbanes-Oxley
• SAS 70
• HIPAA
• ISO 9001:2000