Regulatory Affairs Service Provider in South Korea
DDReg provides expert-led Regulatory Affairs Services in South Korea to help companies achieve seamless product approvals and lifecycle compliance.
The Ministry of Food and Drug Safety (MFDS) is the central authority overseeing the registration, manufacturing, and distribution of pharmaceutical products and medical devices in South Korea. As part of its mandate, MFDS enforces Good Manufacturing Practices (GMP) to enhance safety control systems. Supporting institutions such as the National Institute of Food and Drug Safety Evaluation (NIFDS), Medical Device Information and Technology Assistance Center (MDITAC), and Pharmaceutical & Medical Device Safety Bureaus work collaboratively under MFDS to manage product registration, monitoring, and compliance.
Pharmaceutical Regulatory Affairs in South Korea
Pharmaceutical products in South Korea are regulated under the Pharmaceutical Affairs Act, which classifies them into drugs and pharmaceutical ingredients. Drug products are further sub-categorized into new drugs, generic drugs, pharmaceuticals requiring data submission. Even if not classified as new, certain drugs must submit safety and efficacy data particularly when changes in dosage form, route of administration, or indications are involved. These submissions are essential for obtaining MFDS product registration and market access.
Our Regulatory Consulting Services In South Korea Portfolio Covers
Why choose DDReg as your South Korea Regulatory Partner?
As your South Korea regulatory affairs consultant , DDReg supports clients across all regulatory phases with custom strategies tailored to local requirements. Our regulatory team ensures that all pharmaceutical regulatory affairs in South Korea align with the most recent MFDS guidelines, helping clients minimize delays and maximize regulatory success.
We work as your extended regulatory team to deliver timely product approvals, accurate documentation and filings, strategic submission planning, expert-level market intelligence.
- MFDS Regulatory Consulting Services
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- Regulatory Certification
- eCTD Regulatory Publishing and Submission
- Regulatory Labeling
Our Regulatory Affairs Consulting Services in South Korea portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
