CPhI World Wide 2022 is coming! Medicilon is excited to exhibit at the conference. Our European team looks forward to meeting you in person to discuss how our services and capabilities would support your current research needs and expedite your drug discovery and development programs. Our EVP of Pharmacy (APIs + Preparations), Dr. Zhenrong Guo, will also be at booth 80M47.
Date: 1 – 3 November 2022
Location: Messe Frankfurt, Germany
CPhI Worldwide is the world’s most important gathering of the pharmaceutical industry. CPHI Global events are the world’s most important gatherings for ingredients, machinery, equipment, technology, package and contract service suppliers, distributors, and buyers from the pharmaceutic industry. Unlock endless opportunities to grow your business.
Fully Integrated Preclinical Drug Discovery and Development Services
Medicilon is an integrated contract research organization (CRO), providing comprehensive one-step new drug R&D for pharmaceutical enterprises and scientific research institutions around the world. With our experience in serving domestic and foreign biomedical industries, we have built an integrated technology platform covering key technologies in drug discovery, pharmaceutical research, and preclinical research, in a bid to provide comprehensive preclinical new drug R&D for the global biomedical industry.
At Medicilon, we are dedicated to helping our clients develop their research and discovery programs from the initial ideas all the way through the Investigational New Drug (IND) filing phase. Our services span across medicinal chemistry, biology, API, CMC, formulation, and preclinical studies. We provide flexible business models, including stand-alone Fee for Services (FFS) and fully integrated FTE services. In addition, our facilities are GLP/GMP compliant, US-FDA, China NMPA, and AAALAC accredited. All study reports can be presented in SEND format, supporting the dual filing of IND applications in the US, EU, and China.
18+ years of experience in new drug R&D
Active clients worldwide
New drug discovery scientists and service personnel
Square meters of Laboratory floor space
Projects successfully approved by FDA, NMPA, EMA, and TGA
Dr. Guo has been deeply involved in the field of innovative drug R&D for more than 30 years and has rich experience in CMC R&D and management. Dr. Guo has successfully published 26 papers in top international journals, obtained a total of 33 patents in the United States and China, and led the R&D and production of more than 10 new drugs, including the fields of tumor, diabetes, and other major diseases.
Medicilon CMC Services
Medicilon provides comprehensive pharmaceutical analysis services, including methodology development and verification, analytical testing and release, stability study, scale separation, and CMC filing documents.
CMC services for IND/CTA, NDA/MAA, and ANDA filings
❖High-quality, fast, and low-cost one-stop services
❖One-stop services for drug analysis, research and development, stability, quality control, and CMC regulatory documents
❖Applicable to domestic and overseas filings
Medicilon currently features a cGMP-based API production line based on IND. From preclinical laboratory-scale testing and process development to commercialized production, we meet the needs of our clients throughout the comprehensive supply chain, including R&D, purchase, and production. From the mg- and g-level to kg-level, our processes allow flexible adjustments to fit in client innovative process R&D and scale production.
From QBD-oriented process design to process R&D in laboratories, commercialized production to data-based filings, our analysis, and quality inspection teams promise professional services and comprehensive analytical research, including method development and verification, process verification, impurity identification and separation, API and intermediates research, and API stability tests.
Professional technology platform for insoluble innovative drugs. With mature and complete technologies such as solid dispersion, micronization, solubilization, inclusion compound, in vitro dissolution/in vivo PK comprehensive evaluation, etc., we can deal with the common solubility and permeability problems of candidate compounds for new drugs.
Professional high-end preparation technology platform. For inhalation administration, ophthalmic administration, transdermal administration, sustained-release administration, and new particulate system administration, our Preparation Department has continuously innovated and improved its technical service platform and accumulated practical experience to meet the requirements of the times and clients.