EMA/EDQM Regulatory Compliance Consulting
Saxon Interglobal Associates offers EMA/EDQM Regulatory Compliance Consulting and Submission Services for the API and FDF market segments.
We can identify your EMA/EDQM Regulatory Compliance Submissions requirements and help you create a scalable strategy to plan, and implement the most cost-effective and risk-averse practices for your EDQM Submissions.
We help firms avoid costly EU Regulatory Compliance warnings or penalties by risk management of EDQM Submissions.
SIA maintains an CESP gateway to service your EDQM Submission requirements for:
–Certificate of Suitability (CEP) applications
Types:
–Active Substance Master File (ASMF)
–Marketing Authorization Application (MAA)
–Marketing Authorization Variation (MAV)
Saxon Interglobal Associates offers EMA/EDQM Regulatory Compliance Consulting and Submission Services for the API and FDF market segments.
We can identify your EMA/EDQM Regulatory Compliance Submissions requirements and help you create a scalable strategy to plan, and implement the most cost-effective and risk-averse practices for your EDQM Submissions.
We help firms avoid costly EU Regulatory Compliance warnings or penalties by risk management of EDQM Submissions.
SIA maintains an CESP gateway to service your EDQM Submission requirements for:
–Certificate of Suitability (CEP) applications
Types:
- Original Application
- Response to a Deficiency Letter
- Additional data updates
- Revisions
–Active Substance Master File (ASMF)
–Marketing Authorization Application (MAA)
–Marketing Authorization Variation (MAV)