Services – DADA Consultancy

Services

DADA Consultancy is a highly specialised and independent consultancy agency in international regulatory affairs of human and veterinary medicinal products.

Regulatory Affairs

Early Access programs
Health-based exposure limits (HBEL)
EU language translations
PIL user testing

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Pharmaceutical Development

Product development
European Drug Master Files
Certification of Suitability to EP monograph
Impurity profiling

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Pharmacovigilance

Audits
Communication with National Competent Authorities
EU Qualified Person for Pharmacovigilance (QPPV)
Expedited reporting

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Pharmaceutical Safety and Efficacy (PSE)

Clinical Trial Authorization Applications
Phase 1 Environmental Risk Assessment (ERA)
Quantitative Structure-Activity Relationship (QSAR) assessment according to ICH M7
Early Access programs

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Market Access and Advertising Compliance

Advertising compliance
Market access

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QA Compliance

QP and RP services
GxP auditing services
Licenses
GMP and GDP training

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Contact

Contact us

Our customer support is available from 9am to 5pm:

+31 24 373 03 09 office@dada.nl

Godfried Bomansstraat 31
6543 JA Nijmegen
The Netherlands

Business hours

Monday – Friday: 9am – 5pm
Saturday: Closed
Sunday: Closed