Company Profile
Many of our products have obtained DMF registration from the US FDA, and our team of peptide experts has extensive experience in peptide research and development. Products have successfully landed in China, the United States, Europe, Japan and other markets. ThinHeal is committed to building an international peptide delivery system and providing customers with one-stop service..
The company is positioned as an international-level peptide delivery platform. It has research bases in China and the United States and adopts international R&D standards to provide customers with one-stop solutions for peptide products. Provide customers with technology development and international filing and registration services for new peptide products, a full set of peptide impurities, and consistency evaluation. At the same time, the company has established a scientific and complete peptide research and development system and a quality assurance system that meets international application requirements to ensure the scientificity and compliance of project research and development.
The scientific research team has nearly 20 years of experience in peptide research and development, has completed international applications for multiple varieties, and has rich marketing experience in complex preparations ANDA in the United States, Europe, Japan and other places.
The company has built an international R&D standard experimental platform of nearly 2,000 square meters, equipped with advanced instruments and equipment such as waters high-performance liquid chromatography, mass spectrometry system, gas chromatograph, freeze dryer, etc. to ensure the scientific and orderly progress of R&D projects.
Doctors are benevolent, and benevolent people are trustworthy. The sea accepts all rivers, and tolerance is great. ThinHeal Pharma adheres to the concepts of pragmatism, integrity and inclusiveness, actively promotes the development and innovation of the peptide industry, and provides accessible solutions to the majority of patients!
Core advantages
1. Complete quality management system: The company has established a quality management system covering the entire life cycle of peptide based on China GMP, 21CFR Part 210, 211, EU cGMP Volume 4, and ICH guideline, providing comprehensive and complete quality assurance for the entire product process.
2. Mature project management advantages: In terms of project management, the team fully implements the ICH guideline requirements according to customer needs. The team has high-end peptide research and development experience and international application experience to ensure the smooth development of the project.
3. Solid cGMP management advantages: The team has rich cGMP management experience and implements cGMP management for product transfer, process verification and commercial production according to the requirements of different declaration places (including China, the United States, the European Union, and Japan).
4. Advantages of cost control management: From peptide synthesis route selection, purification process optimization to full-process quality control, we always put customer interests first and achieve effective cost control while ensuring product quality and regulatory compliance.
5. Mature process development technology: platform-based peptide process development technology.
In terms of peptide raw materials: up to 40 peptide synthesis experiences, including but not limited to the synthesis of linear peptides/cyclic peptides/polypeptide products containing multiple disulfide bonds; solid phase/liquid phase peptide synthesis and assembly coupling; peptide modification and polypeptide synthesis Cyclic peptide synthesis.
Peptide preparations: including process development and quality control of peptide injections, peptide oral sustained-release preparations, and long-acting peptide injections, as well as experience in stability research and scale-up production.