modified new drugs
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Pharmaceutical Research Services
Our company has an pharmaceutical R&D team with full experience in sustained-release and controlled-release preparations, solubility enhancement of poorly soluble drugs, topical preparations, orally disintegrating preparations, soft capsules, liquid preparations, and eye drops. We provide generic drug API and preparations development as well as innovative drug preparations development, including pre-formulation studies, formulation screening, process development, quality studies, stability studies, and other pharmaceutical research services and technical support. We also assist in selecting suppliers of APIs, excipients, and packaging materials, developing and upgrading internal control standards for materials, supporting API/preparations companies to upgrade and maintain the manufacturing and quality management system, and helping them to complete process validation.
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Consistency Evaluation Services
Passing the generic drug consistency evaluation or being listed in the Chinese Approved Drug Products Directory is an essential requirement for companies to participate in tender and centralized procurement. If a generic drug becomes the "first" or "among the top three" to pass the evaluation, it brings significant market and economic benefits. Otherwise, there is a high risk of losing market share or even the drug approval.
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Our company has a professional team specializing in pharmaceutical R&D, regulatory registration, and quality management. With extensive project experience, we can provide professional analysis, advice, and solutions to clients on pharmaceutical research and registration-related issues — such as project initiation investigation, RLD selection, quality studies, drug registration filing, and generic drug consistency evaluation. We offer the following technical consulting services:
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In 2017, China introduced the "Marketing Authorization Holder (MAH)" system for drugs, opening a door for R&D institutions and researchers to own their own drugs. At the same time, it also requires them to assume a series of corresponding legal responsibilities — covering the entire drug lifecycle: from R&D, supply chain management, manufacturing (with contract manufacturers), distribution and sales, adverse reaction monitoring, product lifecycle management, to product registration changes and renewals.
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