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Daily: 9.30 AM–6.00 PM
Sunday : 9.30 AM–1.00 PM
Holidays: Closed
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Regulatory support
Our regulatory affairs services are designed to help clients smoothly cope with the complex and ever-changing global drug registration environment. Whether it is IND in the early development stage or NDA/ANDA submission before marketing, we can provide professional, compliant and efficient support. Through high-quality CMC document writing and global registration strategy planning, we help clients accelerate product launch, reduce compliance risks and improve project success rate. 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 R&D needs.
Regulatory Support
We provide one-stop regulatory support services to global pharmaceutical and biotechnology companies, covering the entire process of drug development and commercialization.
DMF Registration and Filing Service
We assist customers in writing, organizing and submitting drug master files (DMFs) to ensure compliance with the requirements of international regulatory agencies such as FDA, EMA, NMPA, and accelerate the review process.
We provide full-process support for new drug applications (NDA) and generic drug applications (ANDA), including material preparation, regulatory consultation and communication coordination.
We support the non-clinical trial application (IND) of innovative drugs, including early communication strategies, writing submission materials and interaction with regulatory agencies, to help projects enter the non-clinical stage smoothly.
Regulatory Support Service Advantages
- Global Regulatory Compliance: familiar with multiple major regulatory systems to ensure that the information meets international requirements.
- Professional Team Support: a team composed of former regulatory experts, pharmacy doctors and technical personnel with rich application experience.
- Customized Service Solutions: tailor-made support strategies according to the customer's project stage and needs.
- Efficient Communication and Collaboration: maintain efficient collaboration with customers and regulatory agencies to improve the success rate of applications.
Why Choose Our Service
- Years of Industry Experience: successfully supporting drug registration projects in multiple international markets.
- Cross-domain Capabilities: covering a variety of drug types such as chemical drugs, biological drugs, cell and gene therapy.
- Quality First: strict document review mechanism to ensure the scientificity and standardization of application materials.
- One-stop Service: from strategy formulation, material writing to regulatory communication, covering the entire process.
Application Areas of Regulatory Support
- Small molecule drug
- Biological products
- Generic drugs
- Innovative drugs
- High-end preparations
- Cell and gene therapy products
- Medical devices/combination products
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.
