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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.

IND registration declaration

Investigational New Drug (IND) registration application is an important step for pharmaceutical companies to apply to start non-clinical trials. The purpose of IND application is to obtain permission to conduct non-clinical trials of new drugs. Protheragen BioNucleics focuses on providing high-quality, full-process oligonucleotide drug formulation development services, covering a variety of administration routes and dosage forms to meet different non-clinical and R&D needs.

IND Registration Service

Registration Strategy Formulation: Our team will conduct due diligence at the beginning of the project and select the appropriate IND application path.
Non-clinical Research Support: Provide professional pharmacology and safety pharmacology research design, and can conduct professional toxicology research, support non-clinical research compliance review and report writing.
Application Material Writing and Submission: CTD format arrangement, eCTD application document preparation, communication support with NMPA/CDE (including IND meeting application).
Registration Affairs Management: IND application submission and tracking, CDE technical review communication response support, defect item response and supplementary material writing and IND post-approval services.

New Drug Non-clinical Trial Application Solutions

Program Design: regulatory consultation, project evaluation, strategy design
R&D Services: pharmacy (APIs, preparations), efficacy, DMPK, toxicology
Integration Services: budget evaluation, time planning, project management, coordination of various modules
Registration Application: registration application materials writing and organization, registration application submission, communication with regulatory agencies

R&D Services

APIs
Formulations
Pharmacokinetics (DMPK)
Pharmacology
Toxicology (outsourcing)

Service Objects

Biomedical enterprises
Innovative drug research and development companies
Scientific research institutions or university scientific and technological achievement transformation projects

IND Registration Application

Our Advantages

Familiar with regulations and registration strategies in many parts of the world
Successfully applied for multiple oligonucleotide drug IND projects
Professional team (CMC, toxicology, registration coordination)
Provide one-stop service to reduce corporate communication costs
Industry-leading integrated non-clinical R&D expertise

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.