Comprehensive Regulatory Support for All Phases of Development
We provide regulatory affairs strategy and operations for global pharmaceutical, biotech, and medical device companies.
With highly experienced regulatory experts in China and the US, we are an extension of your regulatory team. Let us streamline your product development with cutting-edge regulatory strategies, author your documents, manage interactions with regulators or serve as your local agent for a smooth and efficient development process.
Pharmaceuticals
Regulatory submissions for both new molecule entities and generics in areas such as infections, oncology, digestive system, immunology, and endocrine metabolism.
Experience includes small molecules, ADCs, biologics, biosimilars, radiopharmaceuticals, cell and gene therapies, vaccines, nucleic acids and more.
Experience includes small molecules, ADCs, biologics, biosimilars, radiopharmaceuticals, cell and gene therapies, vaccines, nucleic acids and more.
Medical Devices
Clinical trial applications for medical devices.
Regulatory affairs services for the initial registration, renewal and changes in registration for medical devices produced and imported into China.
Pre-submission evaluations and filings for innovative medical devices, clinical evaluation report writing, guidance, and filing for complex product classifications and attribute determinations.
Regulatory affairs services for the initial registration, renewal and changes in registration for medical devices produced and imported into China.
Pre-submission evaluations and filings for innovative medical devices, clinical evaluation report writing, guidance, and filing for complex product classifications and attribute determinations.
Global Regulatory Services
Global Multi-Regional Regulatory Expertise
China Australia
US FDA South America
EU EMA MENA (Middle East & North Africa)
Southeast Asia
China Australia
US FDA South America
EU EMA MENA (Middle East & North Africa)
Southeast Asia
A Team of Experts
Our core team excels in regulatory submissions for all product categories. Our deep understanding of regional regulatory requirements ensures accurate, complete submissions while fostering clear communication with regulatory agencies to streamline product development.
Efficient and Reliable Management
SDM’s comprehensive SOP system, aligned with international standards, ensures high-quality regulatory services. From product registration strategy and document preparation to project management, we deliver efficient solutions that meet timelines and support successful product commercialization.
Want to know how to ensure your investigational product pathway plan correctly anticipates what the regulatory authorities will require for optimal product development? We can help you establish clear communication channels with the regulatory reviewers.
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