FDA Regulatory Pathways and Submission Types
Some of the pathways to market you may not have heard much about.
PMA and PMA supplements
Combination Product – Read more in SPECIALTY SERVICES
Investigational Device studies may...
Reduce costs and time to market with efficient development systems
All successful regulatory submissions are supported by FDA compliant Design Control and Review systems. Quality System Regulations (21 CFR 820 :QSRs) and ISO 13485 require documented design review according to...
Qualification Planning and Testing requires coordination of the development of protocols with product claims, risk mitigation and performance requirements. Qualification planning pulls together Design Control compliance, regulatory submission requirements, such as development of claims,...
Quality System compliance monitoring has increased by both the US FDA & by the foreign competent authorities & their agencies. Keeping up with best practices is time-consuming. We have the experience to train your staff, & serve as your interface with FDA if needed. We can conduct a Quality...
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