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Regulatory Certification Services  

Regulatory certification services help businesses navigate compliance requirements for products in various markets. They ensure that products meet local regulatory standards for safety, quality, and efficacy.

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Marketing Authorization Holder Services

Marketing Authorization Holder (MAH) services manage the legal and regulatory responsibilities for a product's approval, distribution, and post-market surveillance, ensuring compliance with local regulations.

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eCTD Publishing and Submission Services 

eCTD Publishing and Submission Services streamline the regulatory submission process by converting documents into electronic Common Technical Document (eCTD) format, ensuring compliance with global standards.

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Drug Labeling Compliance & Artwork Review Services

Our Drug Labeling Compliance & Artwork Review Services ensure that your product labels meet regulatory standards, helping you navigate legal requirements, avoid costly mistakes, and streamline market approval.

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Quasi Drugs: Regulatory & Commercial Considerations for Japan and South Korea

Navigating Quasi-Drug Regulations and Market Entry in Japan and South Korea

In the dynamic Asia-Pacific market, quasi drugs represent a unique regulatory category that bridges the gap between cosmetics and pharmaceuticals. Particularly in Japan and South Korea, quasi drugs have gained traction for their hybrid benefits offering therapeutic claims while maintaining a relatively simpler regulatory pathway compared to full-fledged drugs. 

Understanding the regulatory and commercial landscape of quasi drugs in these two key markets is essential for global companies aiming to enter or expand in East Asia. This article explores the updated guidelines, approval requirements, and commercialization opportunities for quasi drugs in Japan and South Korea. 

What Are Quasi Drugs?

Quasi drugs are defined as products that have mild pharmacological effects or physiological functions. They may not be as potent as traditional drugs, but they go beyond the scope of general cosmetics. These products can include: 

Medicated shampoos 

Hair growth tonics 

Anti-acne treatments 

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Know more about our CMC Advisory Regulatory Services

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Regulatory Strategies

Regulatory Strategy Consulting is a specialized service designed to assist pharmaceutical companies in creating a global regulatory strategy that simplifies submissions, speeds up approvals, and ensures compliance with various international standards. At Life Science Services, we provide customized solutions that cover all aspects of regulatory planning and implementation.

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New Product Marketing Authorizations

DDReg is a trusted partner for the global pharmaceutical and biotechnology industry seeking faster market entry through timely grant of Marketing Authorization for pharmaceutical or biologics products. With over a decade of expertise, we have successfully managed New Product marketing authorization and global regulatory approvals across 120+ countries. Our team of experts understands the complexities of the regulatory process and provides tailored solutions to streamline the process. From pre-submission reviews, gap analysis & remediation to dossier compilation and agency query responses, we ensure a seamless pathway to approval. With our in-depth regulatory knowledge and commitment to quality, Life Science Services helps you accelerate market entry while maintaining full compliance with ICH, WHO, and regional health authorities. Also read Pharmacovigilance Services

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Gap Analysis and Remediation

DDReg is a reliable partner for regulatory gap analysis and remediation services in the pharmaceutical industry, bringing extensive expertise, a strategic approach, and a proven history of success. Our team of regulatory professionals carefully examines dossiers, technical documentation, and compliance frameworks to pinpoint gaps that may cause approval delays. We offer tailored solutions to meet your specific regulatory compliance and gap analysis needs, ensuring your products adhere to global regulatory standards. With a focus on accuracy, efficiency, and current regulatory knowledge, Life Science Services supports pharmaceutical companies in navigating complex regulations, red

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Pharma Regulatory Affairs

Pharma Regulatory Affairs involves ensuring that pharmaceutical products comply with all regulatory requirements before reaching the market. This includes navigating complex laws and guidelines, preparing submission documents for regulatory agencies, managing product approvals, and maintaining ongoing compliance to ensure safety, efficacy, and quality standards.

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Life science services

Life science services encompass a wide range of offerings aimed at supporting research, development, and innovation within the life sciences sector. These services include laboratory testing, clinical trials, regulatory compliance, data analysis, biomanufacturing, and consulting, all designed to advance healthcare, biotechnology, and pharmaceutical industries.

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Global submission complexity varies widely across markets and understanding these levels is key to smarter planning and faster approvals.

We've mapped out the perceived difficulty of regulatory submissions by region to help you anticipate challenges and align your strategy accordingly.

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A label is more than data on a package, it's your product's first line of communication, compliance, and credibility.

At DDReg, we partner with businesses to craft regulatory labels that are clear and aligned with regulatory standards.

Let your label reflect the quality and integrity behind your product.

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Regulatory Landscape for Biosimilars in Southeast Asia

The biopharmaceutical landscape is at a pivotal moment as biosimilars—therapeutic products that closely resemble and are clinically equivalent to existing biologic drugs—gain traction. In Southeast Asia, a region characterized by diverse healthcare infrastructures and economic inequalities, biosimilars offer a transformative opportunity to enhance access to essential biologic therapies. Yet, their successful adoption into national healthcare systems depends heavily on regulatory readiness and cross-border alignment.

As regulatory frameworks across the region continue to mature, it is essential for stakeholders—including pharmaceutical companies, regulatory professionals, healthcare providers, and policymakers—to grasp both the shared features and country-specific nuances of biosimilar approval pathways. In this blog, we examine the current biosimilar regulatory landscape in major ASEAN countries, highlight key challenges, and discuss strategies to build a robust and sustainable biosimilar ecosystem.

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