Toggle navigation
Regulatory Services
R&D Phase
Product Development
Scientific Advice
Clinical Trial Application / Early Access
Orphan Drug Designation
Regulatory Strategy
Due Diligence / Gap Analysis / Audits
Registration
Medicines (MAA)
Dossier Preparation
SME Application
Modules 1-5 (CTD)
eCTD Publishing
User Testing of Patient Leaflet
Procedure Management
National Procedure / Mutual Recognition
Decentralised
Centralised
Herbals (THR)
Borderline (ACBS)
Post Approval
Variations / Renewals / Sunset
Change of Ownership
A to Z of Regulatory Services
Pharmacovigilance Services
Pharmacovigilance Service Providers
Drug Safety Monitoring
Pharmacovigilance Outsourcing
Clinical Trial & Marketing Authorisation
Medical Information Services
Product Commercialisation
In Licensing / Out Licensing
Market Analysis / Product Launch
New Markets / New Territories
Unlicensed Medicines
Reclassification
Technology Transfer
News
About us
Contact us
News
EMA update
EMA encourages companies to submit quality type I variations for 2014 by end of November
28th October 2014
For more information or an estimate, contact us »
Written Confirmations for export of Active Substances manufactured in the UK Post Brexit
18th June 2019
MHRA GDP Pilot Scheme - OBERA: Office Based Evaluation and Risk Assessment programme
26th April 2019
Use eCTD for all regulatory activities in National Procedures (NP) by 1 January 2019
18th January 2019
Revised guideline to assess risk of human medicines for the environment
4th December 2018
Submitting regulatory information on medical products if there’s no Brexit deal
25th September 2018
Report from EMA - Industry survey on Brexit preparedness
13th July 2018
Variations Required: Concomitant use of benzodiazepines / benzodiazepine like products and opioids
3rd May 2018
MHRA's Guidance on GxP data integrity
28th March 2018
Brexit Update: Ireland and Denmark to drop fees for RMS transfer post-brexit
13th February 2018
An overview of the EU’s orphan designation programme - EMA Factsheet
2nd January 2018
EMA to relocate to Amsterdam, the Netherlands
20th November 2017
EU-US mutual recognition of inspections of medicines manufacturers enters operational phase
1st November 2017
Better labelling of excipients for safe use of medicines
16th October 2017
MHRA's recently published guidance on human factors
19th September 2017
EMA's Revised guideline on first-in-human clinical trials
9th August 2017
EMA's Pre-submission checklist for type II variation applications
11th July 2017
EMA Regulatory Guidance for industry to prepare for the UK’s withdrawal from the EU
1st June 2017
EMA Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use
3rd May 2017
Changes to MHRA payment of fees
31st March 2017
New MedRegs blog
9th February 2017
Standards for biological medicines - understanding them and how they make a difference
13th January 2017
Notification of intent to import an unlicensed medicinal product
7th December 2016
Export medical devices: special rules
8th November 2016
EU-US collaboration to boost medicine development for rare diseases
28th September 2016
Pharmacovigilance Inspection Metrics Report April 2015 - March 2016
6th September 2016
MHRA - Updated Statement On The Outcome of The Brexit Referendum
21st July 2016
Introduction of a 'regulatory contact point' for marketing authorisation holders
17th June 2016
Single, central platform now mandatory for all PSURs
10th June 2016
CMDh Update For New Applications
15th April 2016
EMA update
19th January 2016
Who we help:
Generic
Innovator
Biosimilar
Over the counter
Herbals
Food / Cosmetic / Device
New to Europe
New to registering medicines
