Regulatory Affairs Services Provider in Hong Kong
Hong Kong is a critical life sciences hub in Asia, offering strong regulatory alignment with international standards and access to regional markets. However, successful market entry and long-term compliance require a clear understanding of Hong Kong’s territory-specific regulatory framework. At DDReg, we provide specialized Regulatory Affairs Services in Hong Kong, supporting global and local pharmaceutical, biotechnology, and medical device companies with market entry, expansion, and full lifecycle regulatory support.
With a dedicated team of regulatory professionals and hands-on experience with Hong Kong authorities, DDReg acts as a trusted Regulatory Affairs Consultant in Hong Kong, delivering strategic guidance and operational regulatory execution across the product lifecycle.
Understanding the Hong Kong Regulatory Framework
Regulatory oversight in Hong Kong is primarily managed by the Department of Health (DH), Hong Kong SAR, under a well-defined but documentation-intensive regulatory system. Key regulatory bodies and frameworks include:
- Department of Health (DH) – primary authority for pharmaceutical products
- Pharmacy and Poisons Board (PPB) – responsible for drug registration and licensing
- Pharmacy and Poisons Ordinance (Cap. 138) – governing legislation for pharmaceuticals
- Medical Device Administrative Control System (MDACS) – regulatory framework for medical devices
- Alignment with ICH, WHO, and PIC/S guidelines
As an experienced Hong Kong Regulatory Services provider, DDReg works closely with local regulatory requirements to ensure efficient approvals, reduced regulatory risk, and sustained compliance.
Our Regulatory Expertise in Hong Kong
Our Regulatory Affairs Consulting Services in Hong Kong Include
- Regulatory strategy and Hong Kong market entry pathway assessment
- Product classification and local compliance mapping
- Pre-submission regulatory planning and readiness assessments
- Preparation, publishing, and submission of dossiers (ICH CTD format)
- Pharmaceutical Registration in Hong Kong (new drugs, generics, variations)
- Medical Device Registration in Hong Kong under MDACS
- Labeling, IFU, and packaging compliance (English and Chinese requirements)
- Authorized local agent and in-country regulatory representation support
- Coordination with the Department of Health and Pharmacy and Poisons Board
- Gap analysis and regulatory remediation planning
- Lifecycle management, including renewals, post-approval changes, and variations
- Regulatory liaison and deficiency response management
- Import license and regulatory documentation support
- Post-market regulatory compliance and change management
- Local regulatory intelligence and monitoring of Hong Kong policy updates
As a Hong Kong Regulatory Affairs Consulting Firm, we provide structured, regulator-ready documentation and proactive authority engagement.
What Sets DDReg Apart in Hong Kong Regulatory Affairs?
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Hong Kong-Focused Regulatory Expertise
Our consultants possess in-depth knowledge of Hong Kong’s regulatory processes, documentation standards, and authority expectations. -
Local Execution with Global Regulatory Perspective
DDReg acts as an extension of your regulatory team, offering scalable support whether you are entering Hong Kong from overseas or managing an established local portfolio. -
Strategic Partner for Regulatory Compliance and Market Access
We go beyond submissions, supporting long-term regulatory compliance, lifecycle management, and risk mitigation in the Hong Kong market.
Our Regulatory Affairs Consulting Services in Hong Kong 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...
