Regulatory affairs
Health-based exposure limits (HBEL)
DADA Consultancy carries out the evaluation of all available pharmacological and toxicological data, and in concordance with ICH guidelines, constitutes a permitted daily exposure (PDE) report including a clear scientific rationale.
Derived threshold values can be used as a risk identification tool and can also be used to justify carry over limits used in cleaning validation.
Services
Other services in Regulatory affairs
- Early Access programs
- EU language translations
- PIL user testing
- Certificate of a Pharmaceutical Product / Free sales certificates
- Reimbursement applications
- Appeals and hearings
- Due diligence and in- and out-licensing support
- Organisational advice
- Scientific advice
- Feasibility studies
- Regulatory strategy
- Marketing authorisation applications
- Marketing authorisation dossiers and maintenance
- Local representative of the Marketing Authorisation Holder
- Expert reports, overviews and quality overall summaries
- Program and project management
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed