Back to top
Real Regulatory
  • Home
  • About
    • Background
    • Meet The Team
    • Service Model
    • Expertise
    • Clients
    • FAQs
    • Careers
  • Sectors
    • Sector Overview
    • Pharmaceuticals
    • Biotech
    • Generics and Known Drug Substances
    • Medical Devices and In-Vitro Diagnostics
    • Borderline Products
  • Services
    • Services
    • A to Z Services
    • Medicinal Products
    • Clinical Trials
    • Clinical Development
    • Devices and Diagnostics
    • Regulatory and Quality Management System Compliance
    • Supply Chain Management
    • Additional Services
  • Support
    • Support
    • Innovator Support
    • Marketing Support
    • Training and Mentoring Support
  • Reports
    • Reports
    • The benefits of a functioning Non-Conformance Management System
    • The Five Whys
    • Documentation: Good documentation is the foundation of a QMS
    • Innovative Products and Start-Up Companies
    • Prospects For Companion Diagnostics
    • Process Mapping and Internal Regulatory Systems
    • Advantages of Niche Providers for Regulatory Affairs
  • News
  • Contact
  • Home
  • About
    • Background
    • Meet The Team
    • Service Model
    • Expertise
    • Clients
    • FAQs
    • Careers
  • Sectors
    • Sector Overview
    • Pharmaceuticals
    • Biotech
    • Generics and Known Drug Substances
    • Medical Devices and In-Vitro Diagnostics
    • Borderline Products
  • Services
    • Services
    • A to Z Services
    • Medicinal Products
    • Clinical Trials
    • Clinical Development
    • Devices and Diagnostics
    • Regulatory and Quality Management System Compliance
    • Supply Chain Management
    • Additional Services
  • Support
    • Support
    • Innovator Support
    • Marketing Support
    • Training and Mentoring Support
  • Reports
    • Reports
    • The benefits of a functioning Non-Conformance Management System
    • The Five Whys
    • Documentation: Good documentation is the foundation of a QMS
    • Innovative Products and Start-Up Companies
    • Prospects For Companion Diagnostics
    • Process Mapping and Internal Regulatory Systems
    • Advantages of Niche Providers for Regulatory Affairs
  • News
  • Contact

Reports

The benefits of a functioning Non-Conformance Management System

The Five Whys

Documentation: Good documentation is the foundation of a QMS

Innovative Products and Start-Up Companies

Prospects for Companion Diagnostics

Process Mapping and Internal Regulatory Systems

Advantages of Niche Providers for Regulatory Affairs

How-can-we-help-plus link to contact page

Real-Regulatory-call-to-action-0102-1600x160

Real Regulatory

Ireland
Unit 9A
Plato Business Park
Damastown
Dublin 15
D15 PA4C

United Kingdom
E-Space North
181 Wisbech Road
Littleport
Ely
Cambridgeshire
CB6 1RA

New-ISO-9001-2015-logo-80x114

LinkedIn

linkedIn real regulatory logo and link

Facebook

U MDR-2020 Deadline The 2020 deadline for compliance with EU Medical Device Regulation (MDR) is fast approaching for medical device companies who want to remain in one of the world’s largest markets. A recent survey (June 2018) by KPMG/RAPS “The Race to EU MDR Compliance” of 200 regulatory and quality professionals at medical device companies around the world. reported the following: • 78 % of medical device companies do not have a sufficient understanding of EU MDR. • 58% of respondents have no strategy in place to remediate gaps in their clinical data or processes for collecting data. • 45% of North American and 29% of European respondents were “not very confident” of being able to meet the regulatory deadline. The survey results show that compliance with EU MDR is a major challenge for medical device companies. RRL can ensure your company is 2020 ready by guiding you through the requirements of the EU MDR and helping you develop a comprehensive EU MDR implementation plan. Contact RRL at https://bit.ly/2zXp9Vb and get 2020 ready now. ... See MoreSee Less

View on Facebook

·Share

Share on FacebookShare on TwitterShare on Google PlusShare on Linked InShare by Email

U MDR-2020 Deadline
The 2020 deadline for compliance with EU Medical Device Regulation (MDR) is fast approaching for medical device companies who want to remain in one of the world’s largest markets. A recent survey (June 2018) by KPMG/RAPS “The Race to EU MDR Compliance” of 200 regulatory and quality professionals at medical device companies around the world. reported the following:
• 78 % of medical device companies do not have a sufficient understanding of EU MDR.
• 58% of respondents have no strategy in place to remediate gaps in their clinical data or processes for collecting data.
• 45% of North American and 29% of European respondents were “not very confident” of being able to meet the regulatory deadline.

The survey results show that compliance with EU MDR is a major challenge for medical device companies. RRL can ensure your company is 2020 ready by guiding you through the requirements of the EU MDR and helping you develop a comprehensive EU MDR implementation plan. Contact RRL at bit.ly/2zXp9Vb and get 2020 ready now. ... See MoreSee Less

U MDR-2020 Deadline
The 2020 deadline for compliance with EU Medical Device Regulation (MDR) is fast approaching for medical device companies who want to remain in one of the world’s largest markets.  A recent survey (June 2018) by KPMG/RAPS “The Race to EU MDR Compliance” of 200 regulatory and quality professionals at medical device companies around the world. reported the following:
• 78 % of medical device companies do not have a sufficient understanding of EU MDR.
• 58% of respondents have no strategy in place to remediate gaps in their clinical data or processes for collecting data.
• 45% of North American and 29% of European respondents were “not very confident” of being able to meet the regulatory deadline.

The survey results show that compliance with EU MDR is a major challenge for medical device companies.  RRL can ensure your company is 2020 ready by guiding you through the requirements of the EU MDR and helping you develop a comprehensive EU MDR implementation plan. Contact RRL at https://bit.ly/2zXp9Vb and get 2020 ready now.
View on Facebook

·Share

Share on FacebookShare on TwitterShare on Google PlusShare on Linked InShare by Email

All set up for the next 2 days at ICDRA @ Clayton Hotel Burlington. Pop in and say hello! ... See MoreSee Less

All set up for the next 2 days at ICDRA @ Clayton Hotel Burlington. Pop in and say hello!
View on Facebook

·Share

Share on FacebookShare on TwitterShare on Google PlusShare on Linked InShare by Email

Load more

View on Facebook

Recent News

  • Deconstructing the revised EMA guideline on manufacture of the finished dosage form
  • RRL News – RRL are recruiting for the role of Senior Regulatory Affairs Consultant – Ireland/UK
  • Real Regulatory News – Leslie Dowling receives TOPRA Distinguished Service Award
  • Notes from Brexit: HPRA-Stakeholder Engagement Event held on 31st Aug 2017
  • CMC Alert: Draft guideline on manufacture of the finished dosage form

Tags

advice affairs clinical cmc consulting dosage dossier ema european experience expertise experts friendly gmp guidance guideline investigational issues knowledge management manufacturing medical medicinal medicines mhra mobile Pharmaceuticals post process processes projects promoted quality real regulatory relevant requirements results risk solutions success systems team technical United Kingdom

Copyright Real Regulatory 2015-18

Privacy Notice - Cookies - Sitemap

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.OkRead more