top of page
Recent Posts
Archive
Tags
New EU MDR - Timelines & Renewed Documentation Requirements
On April 5, 2017, the European Commission has approved the new Medical Device Regulations (MDR) - 2017/745-MDR and 2017/746-IVDR, which...
eCTD Submission Services & Software Solutions FDA, EMA
We offer eCTD Submission & Publishing services to Life Sciences Industry for approval of Drugs/Medicines, Converting Non-eCTD...
Health Authority Queries – Responses | Interactions
The appropriate and timely communication with Health Authorities (HAs) is a key factor for the speedy approval and uninterrupted...
Regulatory Affairs Consulting
As Regulatory Agencies (RAs) all over the world started implementing comprehensive Regulatory systems to control the manufacturing and...
Regualtory Assessment | Gap Analysis
Regulatory assessment is a key activity in registration and life cycle maintenance of Pharmaceutical and Biological products. It is...
bottom of page