Regulatory Affairs

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Regulatory Consulting Service

- Provide continuous regulatory support for product lifecycle management

- Provide global registration strategies and regulatory gap analysis

Filling Documents Writing and Application Service for Drugs Registration

- Prepare customizable registration dossiers in compliance with ICH CTD/eCTD format

- IWrite and/or review CMC-related dossiers for IND (CTA)/MAA (NDA, BLA)/ANDA/DMF (CEP), etc

- Assist in completing domestic and foreign IND or MAA applications, with capability to serve as a trustworthy registration agent in China

- Support professional and timely response support for the authority inquiries

- Provide supports for filling documents updating, supplementary applications, testing for registration, on-site inspection, and product post-approval regulatory activities

- Support on strategic advice and preparation for meetings with regulatory agencies at different development stages (E.g. pre-IND, EOP1, EOP2, pre-NDA, pre-marketing, etc.)

- Assist clients with application of drug manufacturing license according to MAH regulations in China

Information Monitoring Service

- Provide global regulatory updates and briefings

- Provide global registration status update for the competitive products

A Stable Team with Rich Practical Experience in Registration
  • The core members have 10-20 years of practical experience in drug registration, and are familiar with domestic and international registration-related regulations and guidelines
  • The team has successfully completed multiple projects of IND submission, ANDA/NDA submission in China (including import/domestic products, chemical drugs/biologics, and the support for registration testing and on-site inspections)., as well as international registration
  • Multiple products have been approved for marketing
Well-Established and Effective RA Management System
  • Our RA management system includes series of SOPs for management and transaction operations, registration documents templates (including registration plans and dossier requirements, CTD templates of IND and NDA for monoclonal antibodies and ADCs in English and in Chinese, as well as templates for routine supportive documents, etc.), and a regulatory database
  • Our team also keep continuous and timely internal and external training, as well as document management
  • The management system effectively avoids potential gaps in preparation of application and improves the efficiency of registration process
Smooth and Effective Regulatory Communication
  • Through project experience, our team has organized and completed multiple meetings with CDE of NMPA, the US FDA, Germany PEI, and other regulatory agencies. TOT BIOPHARM also has project collaboration experience with the National Institutes for Food and Drug Control (NIFDC) and many major provincial drug testing institutes
  • The team is recognized by regulatory reviewers for our high-quality filling documents
Efficient Internal Communication
  • Smooth collaboration and communication across departments to improve the efficiency of filling documents preparation and registration application