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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.

NDA/ANDA registration declaration

With the development of RNA targeted therapy, oligonucleotide drugs (such as ASO, siRNA, miRNA, aptamer, etc.) have shown great potential in multiple therapeutic areas. The registration of these new drugs, especially new drug applications (NDA) and generic drug applications (ANDA), requires a deep understanding of regulations and rich experience. 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.

Oligonucleotide Drugs NDA/ANDA

Oligonucleotide drugs are a new type of drug used to treat various diseases. In recent years, they have received great attention in the fields of rare diseases, tumors, and neurological diseases. Registration applications for oligonucleotide drugs usually include the following two main paths:

NDA (New Drug Application): Registration path for new molecular entities or innovative drugs
ANDA (Generic Drug Application): Generic registration path for approved drugs

NDA/ANDA Registration Services

We provide one-stop oligonucleotide drug registration and filing services, covering major global markets, including registration strategy formulation, dossier writing, filing execution, GMP compliance support, and follow-up Q&A for innovative drugs (NDA) and generic drugs (ANDA).

Registration Strategy Consulting

Drug positioning and registration path selection (NDA vs ANDA)
Global registration difference analysis
Early development guidance (CMC, non-clinical)

CMC Registration Support

Ingredients (API) and formulation development strategies
Synthesis routes, purification techniques, impurity control
Analytical method development and validation
Module 3 (Pharmaceutical part) writing and review

Non-clinical Support (NDA)

Non-clinical research program design (toxicology, pharmacokinetics)
Non-clinical trial program registration

ANDA Special Support

Reference product selection and Q1/Q2 equivalence assessment
BE (bioequivalence) exemption application or experimental design
Control strategy and quality comparison study
DMF (drug material master file) preparation and filing

Registration Application and Response

eCTD format document writing and organization
FDA/EMA/NMPA electronic application execution
Review Q&A support and communication coordination (Type C meeting, review opinion response, etc.)

GMP Compliance Support

Ingredient and drug product factory audit preparation
CMC compliance assessment and defect rectification suggestions
Registration site inspection support

Applicable drug types

siRNA, ASO (antisense oligonucleotide)
Aptamer (aptamer drug)
miRNA, shRNA
CpG oligonucleotide and other immunomodulators

Service Advantages

Focus on oligonucleotide field: professional team has experience in multiple nucleic acid drug projects
Global registration experience: familiar with regulations and technical requirements in multiple regions around the world
Standardized and efficient data writing ability: in line with eCTD technical standards
Good communication experience with regulatory agencies: improve the first-time pass rate

Registration Application Process

1. Early development stage

2. IND/CTA application

3. NDA/ANDA application preparation

4. Formal application and review process

5. Marketing and subsequent supervision

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.