Based on the clinical value and marketing, the use of innovative pharmaceutical technology to develop modified new drugs with innovative formulations, so that extend the life cycle of drugs and form a differentiated competitive advantage.

Service：

Project investigation and screening, development strategy consulting, preclinical pharmaceutical （CMC）research, etc

Platform：

Dissolving microneedles technology platform, long-acting microsphere industrialization technology platform, in-situ gel technology platform, insoluble drug solubilization technology platform, featured oral modified release preparation technology platform, pulmonary drug delivery technology platform.

We formulate technical barrier plans tailored for dosage forms to manufacture advanced generic drugs; With evaluation of production conditions and equipment and establishment of control indicators, we develop advanced generic drugs for high-quality commercial production.

Service：

Sustained and Controlled release preparations, topical/transdermal  delivery preparations , inhalation preparations, complex injections, etc

Having completed various projects on consistency evaluation and accumulated extensive R&D experience, we can deliver professional services for consistency evaluation.

Preliminary in-depth survey:Formulation process analysis, patent analysis, supplier selection for raw and auxiliary materials, and writing of survey reports and research plans.

Analytical of Reference List Drug (RLD):Reverse Engineering, quantitative and qualitative research of API and excipients (Q1&Q2), formulation process analysis, Impurities Research, and analysis of the crystal and crystal habit of API.

Pre-formulation studies:Characterization of API, functional indicators of excipients, and compatibility of API and excipients.

Formulation Process Studies:Formulation Process (design, screening, optimization) and Scale-up Studies.

Quality Research:Development and Validation of Analytical Procedures, Vitro studies, Establishment of Quality Specifications, and Stability Studies of Drug Products.

Bioequivalence (BE) study:Pre-BE Risk Assessment, Formal BE Risk Assessment, and BE Result Analysis.

Registration Declaration:Regulatory Consulting and Common Technical Document (CTD) Writing.

Service：

Drug Reverse Engineering, Establishment of Quality Specifications of New and Generic Drugs, Development and Validation of Analytical Procedures, and Impurity Research or Impurity Supplement Research.

Our current analysis technologies and equipment include:

High performance liquid chromatography (HPLC), High performance ion chromatograph (HPIC), Atomic absorption spectrometer (AAS), Gas chromatograph (GC), Laser diffraction particle size analyzer (Mastersizer 3000), Transdermal absorption diffusion system (Logan, SYSTEM 918-12, HDC-6T), Polarizing microscope, Hot-stage microscope, Potentiometer, Next Generation Impactor (NGI, Copley), and Respiratory simulator (Copley).

Service：

We provide assessment of formulation stability in accordance with ICH guidelines and customer-specified storage conditions. With the results of stability evaluation, we make professional recommendations on packaging and storage conditions. Assessment tests include stress testing, accelerated testing, long-term testing, and intermediate condition testing.

We set up a specialized platform for drug stability testing with standardized management. With an imported drug stability test chamber, we can conduct stability evaluation that fulfills different conditions.

With extensive experience in renowned pharmaceutical companies at home and abroad and specialized expertise in Chinese and overseas medical laws, regulations and guidelines, our professional team have contributed to many customers’ success of product development.

Service：

Consultant services on project approval, laws and regulations, development strategies, and technical solutions.