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Project Description

Please note that we are not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.

DMF Registration and Filing Services

The growth of the nucleic acid drug industry has made quality registration and declaration of oligonucleotide drugs essential for product compliance before entering the market. Our professional drug master file (DMF) registration and declaration services help companies navigate the regulatory systems to streamline their product registration process. Protheragen BioNucleics delivers expert drug research and development services together with multiple offerings like application document preparation and non-clinical trial management together with regulatory compliance consulting.

DMF Registration Declaration

DMF document writing and organization

Write DMF documents according to various regulatory requirements
Covering the core contents of the drug's starting materials, synthesis routes, in-process control strategies, quality standards, stability studies, etc.
Provide bilingual versions in Chinese and English to ensure the simultaneous progress of international applications

Technical information review and data supplement

Review original development information and identify technical gaps
Provide data supplement suggestions and assist in necessary tests or verifications
Integrate key information such as analytical methods, impurity spectra, and batch consistency

Link with registration applications

Assist customers to cite DMF in IND, registration NDA applications
Support the consistency review of APIs and formulations
Provide pharmaceutical review Q&A support

DMF registration and maintenance

Agency to complete DMF registration and DMF electronic submission
Provide DMF filing number application, update, and maintenance services
Assist in completing the associated authorization (LOA) with the application variety

Service Advantages

Rich Experience: multiple oligonucleotide DMF filing practice cases, covering ASO, siRNA, aptamer and other types
Compliance Guarantee: in-depth understanding of regulations in multiple regions to ensure that DMF content meets different regulatory requirements
Cross-departmental Collaboration: efficient connection with customers' R&D, quality, and regulatory teams to improve data integration efficiency
International Capabilities: provide global DMF filing path planning and support simultaneous advancement in multiple markets

DMF Service Applicable Objects

Oligonucleotide API manufacturers
CDMO/CMO service providers
Drug R&D companies conducting non-clinical research
Customers planning to apply for registration in multiple regions around the world

Service Process

1. Preliminary evaluation and technical research

2. Data integration and gap analysis

3. DMF writing and review

4. Electronic filing and filing submission

5. Follow-up Q&A and maintenance services

Advantages of DMF Registration and Filing Services

As a professional provider of nucleic acid drug technology and registration services, we have accumulated rich practical experience in the field of oligonucleotide drug DMF filing. The following are the five core advantages of our services:

In-depth experience in the field of nucleic acid drugs
Strong compliance, in line with the regulations and standards of many countries
Solid technical background, high-quality data writing
Comprehensive service system, supporting full life cycle management
International registration vision, helping global compliance layout

If you need professional registration services, you can consider working with Protheragen BioNucleics, which provides a range of services including registration document preparation, non-clinical trial management, and regulatory compliance consulting. contact us today to explore how our expertise can accelerate your scientific endeavors.

Our services and products are exclusively for authorized organizations in research, development, or manufacturing and are not intended for direct use by individuals or patients or as medical advice, diagnosis, or treatment.