123ArticleOnline Logo
Welcome to 123ArticleOnline.com!
ALL >> Technology,-Gadget-and-Science >> View Article

Global Regulatory Ectd And Submission Management Services

Profile Picture
By Author: Nancy
Total Articles: 2
Comment this article
Facebook ShareTwitter ShareGoogle+ ShareTwitter Share

Global Regulatory eCTD and Submission Management Services

Global regulatory differences and constant changes to HA submission requirements even in the age of the Common Technical Document and the eCTD, is a challenge to Regulatory Operations teams for proper submission planning and execution.

MakroCare, over the years, has established flexible methodology and infrastructure, for fast and effective global submissions to Health Authorities globally. Whether they are clinical applications, market authorization applications or life cycle management, MakroCare is managing submissions in more than 100 countries. Our experts are connected to deliver integrated services across North America, Europe, and ROW with detailed knowledge of different local submission processes.

MakroCare through its Sub Sure supports clients in:
Managing Global Submissions
Assess the impact of proposed changes in terms of countries impacted, ongoing regulatory procedures, resources required
Coordinate with manufacturing sites and Regional Regulatory teams on regional data/requirements
Cross-function, cross-country and cross-vendor coordination for required information
Create review submission content for all the submissions
Author HA compliant Dossiers
Liaise with Health Authorities
Submission and Approval
Through our shared resources and management techniques, MakroCare offers innovative value-added services which will help teams in getting the scale in shortest possible time to manage uneven loads and ever-changing requirements

Total Views: 24Word Count: 189See All articles From Author

Add Comment

Technology, Gadget and Science Articles

1. The Benefits Of Converting From Php 5 To Php 7
Author: Katalyst Technologies Inc

2. Commercial Or Not, Compare And Get Your Ideal Drone Under Budget
Author: Adam Caly

3. How To Get Your Ipad Touchscreen Fixed
Author: Charlie Wollstonecraft

4. Machine Vision Cameras Inspection System: How Can They Be Useful For Manufacturing Units?
Author: focru012356

5. The Basic Knowledge Of Rapid Prototyping Services
Author: alvarad982stedk

6. Do You Know? Whether A New Car, Or An Old Car, There May Be Air Pollution In The Car!
Author: butle982heiratej

7. Best Wordpress Development Company In Delhi
Author: jit123

8. Best Website Development Company In Delhi
Author: jit123

9. Put Your Safety First And Only Choose The Best Electric Wire Stripper
Author: Adam Caly

10. How To Contorl The Quality Of Inductance Products?
Author: focru012356

11. Safety Guide: How To Responsibly Dispose Or Recycle Lithium-ion Batteries
Author: Enegitech

12. Revamping E-commerce One App At A Time
Author: Katalyst Technologies Inc

13. Best Trade Printers
Author: Tradeprint

14. Event Management Software (ems) Market 2019
Author: Event Management Software (Ems) Market 2019

15. Website And Mobile App Development Company - Ranpariya Consultancy
Author: Ranpariya Consultancy

Login To Account
Login Email:
Password:
Forgot Password?
New User?
Sign Up Newsletter
Email Address: