SERVICES
HOMERegulatory Affairs
In LSK Global PS, RA experts are performing tasks to facilitate the conduct of clinical studies and the registration of products in a prompt and efficient manner throughout the entire development process of medical technologies including medicinal products by understanding the domestic and foreign regulations thoroughly and applying them harmoniously.
Proposal for Strategic Direction
The professional manpower with more than 10 years of experiences in RA help clients save their time and expenses by providing them with prompt feedbacks through close communication with the MFDS reviewers and suggesting a proper regulatory strategy to reach authorization.
Global RA Management
LSK Global PS prepares for the US pre-IND/EOP meeting in alliance with the global partners and performs gap analyses of the required documents and management to obtain the FDA IND/NDA approval.
Process for IND/NDA
-
01IND/NDA
package
preparation -
02Submission
for IND/NDA -
03Regulatory
authority
review -
04Appropriate
reponse during
regulatory
authority
review process -
05IND/NDA
approval -
06Post approval
management
Service Scope
Regulatory documentation and submission of IND/NDA
Management of US Pre-IND/IND/EOP meeting/NDA
Drug Master File(DMF) registration
Orphan Drug Designation(ODD)
Investigator’s brochure development
Common Technical Documentation (CTD) module 2.3 and 3 development
Statement of reasons for waving bridging data
Experience
Study Types
Therapeutic Area
- MAIN :
- 82.2.546.1008
- FAX :
- 82.2.584.9008
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