Regulatory Affairs Service Provider in Japan
The Pharmaceuticals and Medical Devices Agency (PMDA) is the Japanese regulatory body that operates in collaboration with the Ministry of Health, Labour, and Welfare. The PMDA plays a central role in Japan’s regulatory affairs processes by protecting public health through the evaluation of product safety, effectiveness, and quality of pharmaceuticals and medical devices. It is responsible for developing detailed regulatory frameworks, conducting thorough assessments, and ensuring rigorous post-market safety surveillance .
Moreover, the PMDA also provides compensation to individuals who experience adverse drug reactions or biological product-related infections. This falls under a three-pillar system unique to Japan, which integrates:
- Medicinal product review
- Post-marketing safety measures
- Relief services for adverse health outcomes
Our comprehensive system provides PMDA regulatory affairs services. Recognizing the growing importance of international cooperation, the PMDA has actively formed partnerships with agencies across the EU, US, Asia, and other regions. These collaborations support key initiatives under the International Council for Harmonisation (ICH) and contribute to timely, transparent, and effective dissemination of drug safety information to the public. Such global alignment further strengthens Japan regulatory landscape at an international level.
Why choose DDReg’s Regualtory Affairs Services in Japan?
DDReg delivers comprehensive and strategic regulatory services in Japan to meet client-specific needs across all regulatory phases. Our team of expert regulatory consultants continuously monitors updated regulatory frameworks and ensures compliance with evolving PMDA regulatory affairs tandards. This enables high-quality, timely regulatory submissions that reduce time-to-market and enhance approval success.
Whether you're preparing a new product submission or managing post-approval changes, DDReg stands as one of the most experienced regulatory affairs service providers in Japan. We ensure regulatory success and operational excellence across every milestone.
Our commitment to compliance, innovation, and collaboration makes us a trusted Japan regulatory affairs partner for pharmaceutical and medical device companies.
Our Regulatory Consulting Services In Japan Portfolio Covers
- PMDA Regulatory Consulting Services
- Regulatory Strategies and Expert Views
- Regultory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF Support
- Regulatory Certification
- eCTD Regulatory Publishing and Submission
- Regulatory Labeling
Our Regulatory Affairs Consulting Services in Japan 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...
