Overview
To support regulatory pre-approval and post-approval regulatory filings for pharmaceuticals, consumer products, radiopharmaceuticals and medical devices. CONTINUUM has expertise across different regulatory requirements for the entire development cycle of an asset ranging from clinical trial planning to lifecycle management.
Pharmaceutical Regulatory Affairs Service Providers
Trial planning activities:
- Regulatory agency meetings
- IND/IMPD submissions
Marketing and commercialization:
- NDA/BLA/MAA submissions
- DMF submissions
- ANDA submissions
- Agency meetings
- Briefing packages
- Post marketing strategy
- Request Ancillary documents
- Health Authority Queries/Deficiencies– Responses & Interactions
- Labeling Compliance
- Extended Eudravgilance Medical Product Dictionary (XEVMPD) Maintenance & EVWEB Updates
- Clinical/Safety Labeling
- Global Labeling (IB/CDS)
- Regional: USA/Europe Labeling (USPI/SPC)
- ROW e.g. Australian TGA’s Product Information (PI)
- Medical Devices Labeling
- Food/Dietary Supplements Labeling
Our Services
Dedicated Customer Teams & Agile Services
Our strong team of experts ensures the professionalism, expertize, timeliness & cost efficiency required to ensure that your plans are carried out as needed.