Regulatory Filings & Compliance-Asymchem Labs.

Regulatory Submissions and Compliance

Asymchem has a professional and experienced regulatory affairs team, providing full process registration services for drugs including chemical small molecules, peptides, oligonucleotides, ADC, biological macromolecules and more to global clients; closely cooperating with pharmaceutical development team to provide real time regulatory technical support, accelerating the drug R&D process for global innovative drug clients; with rich registration document writing and China and US filing experience, providing guarantee for the implementation of clients' global filing strategies.

Service Capabilities

Regulatory and strategy support

Filing document writing

Registration submission services

On site inspection

Regulatory and strategy support

Fully understand the similarities and differences in filing document requirements and innovative drug accelerated approval channels among global regulatory authorities such as China, US, Europe and more, provide product targeted registration clinical global development strategy.

Provides tailored CMC regulatory strategies based on the development patterns of innovative drugs at different stages, guiding pharmaceutical development plans to ensure regulatory compliance and R&D efficiency.

Preparation of regulatory submissions

IND and NDA CMC filing document writing

Writing of Module 2.4 and 2.6

China and US meeting application document writing

DMF/ASMF/CEP/MF filing document writing

Writing of pharmaceutical supplemental applications and annual reports during clinical period

Writing of post marketing product pharmaceutical supplemental applications, record filing applications and annual reports

On site inspection support

Provide regulatory support for GXP audits

Inspection application document preparation

Assist in receiving on site inspections and unannounced inspections

Regulatory submission execution

China: clinical trial application, supplemental application, marketing application, raw material and excipient record filing, breakthrough therapy application, communication meetings and more

China official qualification and license application: such as drug production license, EU export certificate, export sales certificate, one time import approval and more

US: clinical trial application, marketing application, DMF filing, INTERACT meeting, Type B and C meetings, orphan drug designation application, breakthrough therapy application, IND maintenance, DSUR submission, SUSAR submission and more

Europe: CEP/MF filing and more

eCTD publishing

Project Experience

The team has delivered filing document writing and registration submission work for over 100 China and US IND and NDA projects for clients, completed document preparation and successful filing for multiple US and Europe DMF and ASMF projects.

Communication Channels

Comprehensive and flexible multi channel communication channels, capable of consultation and communication on technical and regulatory issues.

Asymchem has its own team of expert consultants, providing clients with professional consulting services across multiple dimensions, including technology development, regulatory affairs, and review strategy.

Team Members

Core members of the regulatory team have more than a decade of drug registration experience and excellent project management capabilities.

Familiar with non clinical, CMC and clinical research related regulatory requirements and drug filing processes, meeting clients' filing strategy needs.

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