Global Regulatory Services
Whether for one aspect of a project or complete support from inception to approval, we
can help with:
- Strategic planning from design to market for global markets.
- CTD/eCTD preparation and submission for new drugs, generic drugs and clinical trials.
compatibility formatting across global regions.
- Representation/Official correspondent to governing
regulatory bodies (FDA/TPD/EMEA).
- Drug Master File preparation and submission.
- Risk management (warning letters, consent decree representation, recall strategies).
and advertising preparation and review.
- Phase I-III meetings
study initiation and monitoring
Quality systems design and auditing
Inspection readiness and coordination
documentation and implementation