NDA Regulatory Service GmbH

Booth number D-53-6

www.ndareg.com

About us

NDA is a leading regulatory and drug development consultancy, providing Biotech and Pharmaceutical companies of all sizes with advice on the shortest and most economic development path to regulatory approval and patient access.

Our team of over 150 employed Consultants, working out of key sites in Europe and the United States, is complemented by a specialist Advisory Board, comprising the most experienced and well respected experts from regulatory agencies, scientific committees and HTA bodies.

Together, we provide operational support and strategic advice to clients from early drug development through the complete lifecycle of their products, in all therapeutic areas.

In regulatory, we cover CMC, non-clinical, clinical as well as procedure and submission management. Health technology assessment, pharmacovigilance and drug/device combination products are additional areas we focus on.

Products and services

  • US NDA/BLA and EU MAA
  • Accelerated approval pathways (Breakthrough, PRIME, etc.)
  • Regulatory Roadmap
  • FDA communications (end of phase 2 meetings, Ad Comm meetings, etc.)
  • IND preparation and submission
  • CMC, pre-clinical and clinical
  • US / EU development plan gap analysis
  • Scientific Advice Preparation
  • US/ EU ODD applications
  • SME support
  • Pediatric Investigation Plans (PIPs) and US PSP
  • Medical devices support
  • Risk Management Plans (RMPs) & Risk Evaluation and Mitigation Strategies (REMS)
  • Audits for GMP and GLP
  • Qualified Person for Pharmacovigilance (QPPV)

Address
NDA Regulatory Service GmbH
Neumarkter Str. 18
81673 Munich
Germany

Phone: +49 89 35854000
Internet: www.ndareg.com
E-mail: Send message

Contact person

Andrea Aschenbrenner
Director Business Devlepment
E-mail: Send message

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