Global Regulatory Affairs Consulting
To support domestic pharmaceutical and biotech companies and related organizations in global drug development and regulatory response,
KoNECT provides customized global regulatory consulting services across the entire drug development lifecycle.
- Eligibility
- Domestic pharmaceutical/biotech companies, CROs and related organizations
- Services
- Consulting across the entire lifecycle of drug development and global expansion based on U.S. FDA regulations, including regulatory strategy for each development stage, support for communication with regulatory authorities, and advice on regulatory document preparation.
Regulatory Expert Profile
Sung Hoon Jang, Ph.D.
Director, KoNECT Global Regulatory Consulting Group
- Vice President, Elevar Therapeutics (2022.03–2026.03)
- Team Leader, Clinical Pharmacology Review, U.S. FDA CDER (2015–2022)
- Clinical Pharmacology Reviewer, U.S. FDA CDER (2002–2014)
- Ph.D. in Pharmaceutics, The Ohio State University, USA (1999)
Consulting Process
Application
- Submit application form
- Company profile (optional)
Pre-consulting
- Discussion on consulting area and scope
CDA Execution
- Confidential disclosure agreement
Consulting
- Consulting on the requested area
- Application Period
- 2026.4.6 ~ 2026.11.30
- Result
- Notified individually to each applicant
- Contact
- Global Regulatory Consulting Group (+82-2-398-5067, jh.kim@konect.or.kr)