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NDA Group

Johanneslundsv. 2, Sweden

Contact Details

Oxford House
Johanneslundsv. 2
S-194 81 Upplands Väsby

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Phone number: +46 (0)8 590 778 00
Web address: http://www.ndareg.com
Email address: info@ndareg.com

Company Profile

The world’s leading drug development consultancy

صور عزاء We support life science companies all over the world with the single aim to streamline the global development and commercialisation process in order to accelerate patient access to important medical therapies.

NDA comprises over 150 dedicated consultants with industry and regulatory agency backgrounds, supported by a network of over 1,000 scientific, clinical,regulatory and drug development experts. Our advice covers all phases of development and all major therapeutic areas.

On March 1st 2016, NDA merged with PharmApprove – the scientific communications firm in the US, world leaders in preparing and managing successful FDA Advisory Committee Meetings.

NDA supported over 45% of the new medicinal products that were approved in the EU during 2013-2015. In addition PharmApprove’s success rate for FDA Advisory Committee Meetings tops 85% in the same time period.

Our team

The NDA team is divided into two areas designed to support a diversity of client needs:

Expert consultants

NDA has a team of more than 150 employed consultants who actively advise and provide day-to-day support to a broad range of pharmaceutical companies, across therapeutic areas, at various stages of drug development.

The consultants have all been selected for their in-depth knowledge of regulatory affairs, scientific communications,

pharmacovigilance or health technology assessment, their excellent client skills, and their ability to deliver first-class projects.

NDA Advisory Board

The consultancy team is supported by the NDA Advisory Board, and consists of a mix of some of the biggest names in the industry, many of whom have been involved in designing the regulatory and HTA systems in place today. The Advisory Board provides strategic advice and unbiased second opinions to pharmaceutical clients during part of, or the complete end-to-end drug development life cycle

Status: Private Company
Date established: 1997
Number of local staff: 150
Additional services

Strategic and Operational Development Consultancy Service for small molecules and biologics including:

  • Regulatory Affairs 
  • Pharmacovigilance
  • Health Technology Assessments

Expertise

 

The value we bring

NDA offers independent and objective advice and support across the complete lifecycle of a كلام من ذهب drug to ensure optimal regulatory outcomes in Europe and the US, as well as achieving the right price in key markets.

Our services fall into three main categories:

Development

NDA can support with any strategic advice and planning required to get your product ready for application and your team ready for regulatory and pricing and reimbursement discussions.

Application

NDA has the skills and expertise to provide both strategic and operational support to get a product ready for approval with the US as well as European Agencies.

Post authorisation

Once your product has gained regulatory approval, NDA can provide support and advice to make sure your product stays on the market.

With our support you can cut the time and cost it takes to get your product to the patients that need them.

Key Contacts

CEO, NDA Group
Head of Business Development
Mission Statement
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