CR Services
CR Galaxy provides global standard services that allow our client to experience the seamless process, timeline and budget.
Consulting Service
- Drug development consultation
- Regulatory consultation
- Market Access & reimbursement strategies
Regulatory Service
CR Galaxy services include, but aren’t limited to, requesting advice from the Thai FDA, IND/CTA and Product Approval Submissions. We can also serve as your local representative for customs clearance including:
- Application Licensing & Variation Application : eCTD related process, Patient Information Leaflet (PIL), Product characteristic and Leaflet of package
- Post-authorization compliance : PIL usability testing and Safety monitoring program)
Clinical Operation Services
Functional services in clinical operations include;
- Clinical document preparation: protocols, SOPs and manuscripts
- Regulatory Submissions for both IRB/EC and Thai FDA submission
- Clinical site management: study feasibility, site initiation and monitoring, etc.
Medical affairs & Market Research
- Promotional material review and submission
- Advisory Board and KOL (Key Opinion Leader) management.
- Collecting Real World Evidence (RWE) during pre- or post-approval
- Market research e.g. including campaign/ad testing, customer surveys and focus groups
More information, please contact info@crgalaxy.com