Regulatory Affairs / R&D Consultants
Regulatory Affairs / Research and Development Consultants for the Healthcare Industry
OUR MISSION
Responsive and Accurate
In today’s business environment, there is no greater mission for consultants than to provide accurate information in a timely manner. These are the tenets to which we adhere for our clients.
QUALITY
Industry Leading Success Rate
Since it was founded, Med-Script has filed and received approval for hundreds of submissions. These include Clinical Trial Applications, New Drug Submissions and Supplements for Pharmaceuticals, Biologics and Natural Health Products in all therapeutic categories. We have also prepared, filed and received approval for Medical Device Submissions.
SERVICES
Over 60 years of combined regulatory and R&D experience
PHARMACEUTICAL / BIOLOGIC / MEDICAL DEVICE REGULATORY AFFAIRS
- Clinical Trial Applications / Investigational Testing Applications
- New Drug Submissions (NDS)
- Abbreviated New Drug Submissions (ANDS)
- Subsequent Entry Biologics (SEB)
- Supplemental New Drug Submissions (SNDS)
- Notifiable Changes (Biologics)
- Medical Device License Applications (All Classes)
- Natural Health Product License Applications
RESEARCH and DEVELOPMENT / SUBMISSION PLANNING
- Evaluating Quality of Foreign and Domestic Documentation (Gap Analyses)
- GMP / DEL Evaluations
- Coordinating R&D Activities to Regulatory Needs
- Phase I, II and III Planning to Satisfy Regulatory Requirements
- Liaison with CRO's (Protocols, Clinical Monitoring)
- Reporting (Pharmacovigilance / PSURs / DSURs / YBPRs)
- Product Sourcing
eCTD
Med-Script, through its partner Med-Script Development, offers e-CTD services. The software is proprietary (written in-house) and fully validated by Health Canada. By creating its own software, Med-Script Development has avoided expensive software licensing fees charged by other eCTD suppliers and is able to pass these savings on to our clients.
TRANSLATION
Scientific translation from 6 languages
- English
- French
- German
- Spanish
- Portuguese
- Italian
Experience
“Owned by Sue and Soren Wehner, Med-Script has provided services to the Healthcare Industry since 1972”
