Regulatory Affairs

Regulatory 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

  • 01
    IND/NDA
    package
    preparation
  • 02
    Submission
    for IND/NDA
  • 03
    Regulatory
    authority
    review
  • 04
    Appropriate
    reponse during
    regulatory
    authority
    review process
  • 05
    IND/NDA
    approval
  • 06
    Post 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

50403020100 Phase I Phase II Phase III Phase IV IIT Bridging Study Others

Therapeutic Area

119 Projects (Updated on 2019.12.31) Oncology Cardiovascular Ophthalmology Neurology Psychiatry Respiratory Endocrinology Orthopedics Dermatology Nephrology Others