Chemical small molecule drug CRDMO service

Rochi Pharma has comprehensive research, development capabilities and equipment including medicinal chemistry, synthetic chemistry, process research and analytical support. Through our excellent and experienced team of chemists, with professional synthesis technology and familiar various reaction types, we can provide customers with high-quality and high-efficiency chemical synthesis research services, and can synthesize small quantities of compounds. The method is translated into a multi-kilogram process route, and ultimately commercialized by optimizing the process and cost, ensuring that the research and commercialization of the project is completed within very strict time constraints.
 

Medicinal Chemistry:
Rochi Pharmaceutical has a team of nearly 100 medicinal chemists who have experience in new drug development and cooperation with well-known large pharmaceutical companies and biotechnology companies in China and abroad. Under the leadership of internationally renowned and experienced medicinal chemistry leaders, Rochi Pharma can provide customers with value-added medicinal chemistry R&D services covering various targets and disease fields, from active compound discovery, target validation, active compound to lead Compound discovery, lead compound optimization to preclinical drug candidate discovery. Rochi Pharma has successfully helped customers discover multiple preclinical drug candidates in the drug R&D projects in cooperation with customers. Rochi Pharmaceutical’s medicinal chemistry team can provide customers with the following services:
1.Feasibility assessment of new drug targets
2.High-throughput screening and discovery of active compounds based on structural design
3.Active compound to lead discovery
4.Processes from optimization of lead compounds to determination of preclinical drug candidates 
5.Computer-aided drug design (CADD)
6.Research on SAR 
7.Small molecule compound synthesis
8.Synthesis of PROTAC molecules and ADC payloads, as well as lipids, glycolipids and phospholipids, etc.
9.Patent application
With rich experience in medicinal chemistry, to efficiently promote customers' drug research and development, promote the new drug process to fastly enter candidate drug determination and new drug clinical research, and help customers control the cost of new drug development.
Synthetic Chemistry
Our team has professional training, strong chemical problem-solving skills, and maintains close contact and interaction with customers, communicates in a timely manner to ensure the smooth progress of the project, and makes、efforts to achieve the project goals specified by the customers. In FTE's service model, we design synthetic routes for our customers' target molecules, and complete the synthesis and delivery of compounds on time, quality and quantity. These compounds include control compounds, metabolites, reagents, intermediates, molecular fragments and impurities. It can be scaled from milligrams to kilograms (including GMP quality). Our team is proficient in new route design and route optimization. With proficient problem-solving skills and high project success rate, we are able to provide our clients with the following high-quality services:
1.Synthesis of special reagents, intermediates, and molecular fragments
2.Preparation of API or related substances Synthesis of standard substances
3.Synthesis design and preparation of impurities or metabolites
4.Analytical support
5.Delivery of product technical documents and analysis reports
6.Synthesis of working standards
7.Synthesis of stable isotope internal standards
8.Synthesis and resolution of polychiral compounds
9.Synthesis of deuterated compounds
10.High quality product preparation from milligram to kilogram
Process Research
1.Commercial process route development and optimization
2.Commercial process development and optimization through Design of Reaction (DoE) and Design for Quality (QbD)
3.Unit operation studies and validation of key process parameters at each step
4.Studies on the structure, origin and control of impurities
5.Confirmation of process starting materials
Analytical Chemistry：
Rochi Pharma's analytical chemistry and purification & separation team is able to offer high-quality analysis and purification & separation services. We are well-regarded by our clients for our rich experience and problem-solving skills.
Drug impurity analysis:
1.Separating and monitoring impurities in starting materials, intermediates, APIs, and final products HPLC
2.complete data – including 1D/2D NMR, LCMS, EA, HRMS, IR and UV – to identify the structure of the separated impurities Collecting
3.Isolating and identifying the structures of API degradation products by forced oxidation
4.Employment of QNMR to quickly determine the contents of crude materials, intermediates, API and synthetic impurities
5.Preparation of professional filing materials
Analytical Chemistry：
1.Separating and monitoring impurities in starting materials, intermediates, APIs, and final products HPLC
2.complete data – including 1D/2D NMR, LCMS, EA, HRMS, IR and UV – to identify the structure of the separated impurities Collecting
3.Isolating and identifying the structures of API degradation products by forced oxidation
4.Employment of QNMR to quickly determine the contents of crude materials, intermediates, API and synthetic impurities
5.Preparation of professional filing materials
Method development and methodology verification
1.Method development and verification of API (according to NMPA, FDA, EMA and ICH guidelines, as well as requests of clients)
2.Development and verification of residual solvent-related methods (according to NMPA, FDA, EMA, ICH, etc.)
General Analytical Equipment
1.Chromatography: UPLC, HPLC, LC-MS, GC, IC, SFC analysis (including ELSD detection)
2.size exclusion chromatography : Differential Scanning Calorimetry (DSC), Thermogravimetric Analyzer (TGA), X-ray Powder Diffraction (XRPD), Particle Size Determination (PSD), Polarized light microscopy
1.Analysis and identification: Nuclear Magnetic Resonance (NMR), Fourier Transform Infrared Spectroscopy (FT-IR)
2.General Tests: Moisture Meter (KF), Ultraviolet and Visible Spectroscopy (UV-Vis), Polarimeter
3.Normal physical and chemical tests (ROI, LOD, Cl-, SO42-, mp, HM, optical rotation, moisture determination, heavy metal residues, etc.)