NDA - Europe's leading Regulatory Service provider
If anyone can make sure that the best possible medicines reach the patients without unnecessary delay – it’s NDA.
In all we do at NDA, our aim is to shorten the expensive and time consuming process of getting effective and reliable medicines to the market.
NDA can achieve this by providing our clients with an extensive portfolio of services that are optimised to meet the standards of the regulatory authorities.
NDA's clients benefit from our input into development plans and regulatory assistance during the complete life span of their products.
In short, NDA strive to bridge the communication gap between the regulated and the regulators – to the ultimate benefit of patients
Let’s not keep them waiting.
Let’s bring medicines to the world.
08-10 March 2010 DIA 22nd Annual Euro MeetingMonaco, Grimaldi ForumNDA Group invites you to meet the NDA Advisory Board and other members of our expert team at booths 17 & 18 (level+1).
For more information please click here. 16 March 2010, FORUM: "Elektronisches Dokumentenmanagement zwischen F&E und Zulassung", Munich, GermanyMrs Inge Neubauer, Expert in CMC & eCTD Services, NDA, will present:
Praxisbeispiele - Template - basierte Dokumentenerstellung
The seminar will be held in German.
For registration and detailed programme please click here. 18 - 20 March 2010 1st Annual Symposium on Pharmacovigilance, Hong Kong18 March 2010 Drug Safety and Pharmacovigilance
Dr Brian Edwards, NDA:
- International Collaboration in Pharmacovigilance - An Overview
- Post-Marketing Surveillance
19 March 2010 Post-Symposium Training Workshop on Pharmacovigilance For Health Care Professionals
Dr Brian Edwards, NDA:
- Role and Aims of Pharmacovigilance
- Setting Up and Running a Pharmacovigilance Programme
- Basic Risk Management Principles
For more information please click here. 22-23 April 2010 Dr Markku Toivonen speaks on EGA Annual Symposium on Biosimilar MedicinesIn April Dr Markku Toivonen, former CPMP/CHMP member and Chairman of the EMEA Scientific Advice Working party, NDA, is speaking about Unconventional Approaches to Clinical Designs on 8th EGA Annual Symposium on Biosimilar Medicines. He will also participate in a panel discussion on the Challenges of Biosimilar Monoclonal Antibodies.
For more information and to register, please click here. International Pharmaceutical Product Registration.Series: Drugs and the Pharmaceutical Sciences. Second editionNDA experts, Dr Mary Teeling, Dr Brian Edwards, Dr Manfred Haase and Dr Markku Toivonen have all contributed to the latest edition of the "International Pharmaceutical Product Registration".
The publication highlights the latest guidelines issued & being discussed at the International Conference on Harmonisation (ICH) and focuses on CTD, eCTD, Quality, Nonclinical and Clinical Topics.
For more information please click here. February 2010 - NDA acknowledged for it's successThe NDA Group has been acknowledged as a Gasell company - one of Swedens fastest growing companies - by Dagens Industri, the Swedish equivalent of the Financial Times.
At the same time, NDA has been given the highest possible credit rating by Swedish UpplysningsCentralen, UC, Swedens leading business and credit information agency. Electronic Publishing Services at the NDA GroupLet us help your organisation benefit from eCTD.
more information
The NDA Group is an independent consulting organization focused on the strategic and operational aspects of regulatory affairs. NDA provides assistance to both the Pharmaceutical Industry as well as Regulatory Agencies. The ultimate objective of NDA is to help to develop better medicines that reach the patient without unnecessary delay. NDA achieves this objective by critically reviewing client project development plans with the aim that they are optimized to meet the needs of regulatory authorities and then to help to implement those strategies. NDA strives to bridge the communication gap between "the regulators" and "the regulated" to the benefit of patients.
The NDA Group provides services within several different areas such as regulatory affairs, pharmacovigilance and patient safety, readability testing, quality assurance. NDA works with traditional pharmaceuticals, biopharma, medical devices and production processes within the pharmaceutical industry.
The NDA Group also provides expert and strategical advice on development and regulatory strategies and assists the pharmaceutical industry with qualified training.
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