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Medicilon One-Stop Pharmaceutical Research CDMO is an integrated platform that integrates "APIs + Preparations", and is committed to the technological innovation optimization and commercialization of global pharmaceutical processes, from product development, quality research, quality control, production and declaration to help the new drug research and development in saving time and cost for enterprises.
Pharmaceutical CDMO can provide clients with innovative R&D services including process chemistry, formulation and industrial production. Pharmaceutical CDMO fully integrates and deeply connects all phases of drug R&D, including the preclinical study, the clinical trials and the commercialization.
CDMO can optimize R&D projects thoroughly from different perspectives, such as medicinal chemistry, physical/chemical properties, PKPD, etc., based on innovative technology platforms, rich R&D experience, rigid quality system and strict IP protection.
CDMO services could help clients flexibly transfer capacity pressure, reduce the time and cost required to transform products in the trial period.
Medicilon One-Stop Pharmaceutical Research CDMO is an integrated platform that integrates "APIs + Preparations", and is committed to the technological innovation optimization and commercialization of global pharmaceutical processes, from product development, quality research, quality control, production and declaration to help the new drug research and development in saving time and cost for enterprises.
The Medicilon Process Department is deeply involved in the entire industrial chain system of the R&D, procurement and production, from preclinical small-scale synthesis route optimization, process development and scale-up, process validation, quality research to commercial production. Medicilon Process Department could provide innovative process research and development and large-scale production services for the enterprises.
Medicilon Process Department owns the R&D laboratory, the non-GMP scale-up workshop, the GMP standard API workshop and analysis and testing center, GMP-compliant QC laboratory, microbiology laboratory and other test bases, integrating R&D, production, quality control, safety assessment. Medicilon not only provides clients with customized services for GMP production, but also carries out R&D, production, inspection and stability research of innovative drugs clinical phase I/II and generic drugs.
Medicilon's process department is equipped with state-of-art instruments and lab equipment, which enables the accomplishment of clients' drug research and development projects with high standards and efficiency. Our goal is to assist the R&D projects to enter clinical trials in shorter time and effectively help clients to control the new drug development costs.
Apart from our mature capacity in chemical drugs R&D, Medicilon has steadily expanded into the field of biological macromolecules. Medicilon has established the R&D and production systems for small nucleic acid drugs and antibody drugs. within addition, we have advanced our technology in salt and crystal form screening, process safety research, improvement and innovation of quality research systems.
Medicilon preparation CDMO can undertake the whole process of preparation research and development from project evaluation, pre-prescription research, preparation process research, quality research, clinical sample production, stability research and registration filing, which could comprehensively assist the research and development of innovative drugs.
Medicilon has established a variety of dosage form research and development laboratories, non-GMP scale-up workshops, GMP oral solid preparation workshops and GMP-compliant QC laboratories. With advanced equipment configuration and complete functions, Medicilon could flexibly carry out preparations with different production processes and different production batches (1kg-40kg).
Among them, the GMP oral solid preparation workshop can perform services such as raw material crushing, weighing, mixing, granulation, drying, granulation, tablet compression, capsule filling, coating and packaging. Medicilon's clinical production packaging can provide product-labeling options required for single-blind and double-blind clinical trials, and provide different types of clinical production services that comply with current GMP standards according to client requirements.
Medicilon GMP preparation analysis laboratory owns a sophisticated set of quality management system, which can not only meet the QC inspection and requirement for the GMP workshop, but also meet the requirements of long-term stability and accelerated stability research under GMP conditions for the consistency evaluation of generic drugs. The system covers every stage, specifies the responsibilities of departments and corresponding management personnel and establishes a complete documentation system. The system is managed in full accordance with GMP specifications to ensure stable and reliable product quality, traceable quality profiles, complete functions, and flexible production, especially for the preparation of samples for Phase I clinical research.
Medicilon has a professional high-end formulation technology platform, keeps up with the pace of innovation in drug research and development, and meets the diverse requirements of clients. Medicilon has helped a number of innovative drugs to complete the R&D and successfully to get approval for clinical use.
Inhalation Drug Development Platform: Medicilon has extensive research and development experience in dry powder inhaler (DPI), aerosol inhalation and nasal spray formulations. During the research process, the research work will also be fully combined with the requirements of domestic and overseas regulations and guiding principles.
Ophthalmic Drug R&D Platform: Medicilon has rich experience in R&D of different ophthalmic dosage forms such as ophthalmic solution, suspension, eye ointment, gel, etc. Medicilon accumulated the experience of production processes of different ophthalmic preparations such as terminal sterilization, aseptic operation, BFS blow-fill-seal, etc. Medicilon also accumulated rich experience in registration filing.
R&D Platform for Topical Skin Preparations: Medicilon’s R&D Platform for Topical Skin Preparations can undertake the development of ointment, cream, gel and other semi-solid preparations. Medicilon has completed the R&D and filing of several topical preparation research projects for pharmaceutical companies and scientific research units.
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