top of page

CR Services

CR Galaxy provides global standard services that allow our client to experience the seamless process, timeline and budget.

Together at the Top
Consulting Service

- Drug development consultation

- Regulatory consultation 

- Market Access & reimbursement strategies 

Judges_ Hands Pointing At Document
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)

Examining X-ray
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.

City Market
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

bottom of page