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Solutions in Pharma: Innovative and Customized

Technical and Production Services

Provide one-stop overall solutions for pharmaceutical R&D and production services for global customers, including CRO, CMO, CDMO services and contract R&D services such as compound discovery, process development, process optimization, quality research, API production, intermediate production, formulation production and packaging, as well as R&D achievement transformation.

Provide global customers with one-stop services for human pharmacokinetic research and human bio-equivalence research, including screening and determination of clinical research institutions, clinical research protocol design, implementation, clinical monitoring, biological sample analysis and testing, data management and statistical analysis

Provide global customers with one-stop overall solutions of MAH, such as drug research and development, product strategic planning, quality management system audit and counseling, MAH system construction and operation consulting and guidance, pharmacovigilence, pharmaceutical research, etc.

Product Registration and Consultation

Provide global customers with the registration services of new drug clinical and production, including document preparation, review, supplementary information response guidance, translation, transformation and submission, obtaining acceptance numbers, communicating with registration officials, and finally passing the review.

Service Advantages

R&D Advantages

R&D and Design of Drug Life Cycle Competitiveness

The company adheres to the R&D design theory of DDFXBN (Drug Design For X), takes the core competitiveness of products after marketing as the goal of research and development to provide customers with professional R & D services and high-value R & D results.It can ensure the competitiveness of products after marketing.

Strong R&D Power

The company has more than 10,000 square meters of advanced laboratories and invests nearly 15 million dollars to purchase advanced test equipment.

METTLER crystallization monitoring platform
ICP-MS Agilent ICP-MS
LC/MS
GC/MS
Malvern laser particle size analyzer
Atomic absorption spectrophotometer
XRD
Fully automatic dissolution instrument
HPLC
GC

Professional R&D Team

Through cooperation with professional colleges ，universities， research institutes in China and abroad, the drug R&D capability has reached the advanced level of the industry.

Advantageous Technical Fields

API R&D Platform

Inorganic drug API R&D platform

Small molecule API R&D platform

Asymmetric synthesis techniques

Metal catalytic synthesis technology

Ozone oxidation technology

Drug polymorph screening and application technology

Non-biological macromolecular API R&D platform

Convergence degree control technology

Molecular weight determination technology

API pilot production and validation platform

API micronization technology

Crystallization process research technology

API simulation amplification technology

Formulation R&D Platform

Modulated release formulation development platform

Transdermal drug delivery formulations platform

Complex injectable research platform

Hot melt extrusion preparation platform

Odor masking technology platform

Compatibility research platform

Biological Sample Detection Platform

Impurity Research Platform

Perfect Management System

The company introduces an integrated product development process management system (IPD) and implements information management. It formulates a full set of systems, processes and templates for project establishment, procurement, R&D, technology transfer, production and registration, improve the end-to-end process system to ensure that project milestones and key nodes can be effectively achieved on time.

Quality Advantage

The company has professional quality analysis and control ability. We adhere to the highest standards of ICH and control all products strictly in accordance with the latest standards of China-FDA, ICH and EU in order that our products can meet the latest standards for drug exports. We establish the laboratory information management and quality control system from project set up, procurement, R&D, technology transfer, production, registration, etc. Full traceability of product quality are achieved. It can also ensure the authenticity, safety and compliance of R&D data.

Production Capacity Advantages

The company focuses on the production of characteristic APIs. We have the manufacturing ability to supply excellent APIs to the world. Production facilities and equipment are designed in accordance with C-GMP standards. The preparation workshop adopts an automated production system, which realizes the efficiency, intelligence and standardization of preparation production. It can produce tablets, granules, capsules, dry suspensions, oral liquid preparations and other dosage forms. At present, the company has three GMP API production workshops certified by the government, as well as 7 GMP preparation production lines for tablets, hard capsules, dry suspensions and oral liquid preparations.

Vonoprazan Fumarate, Mirabegron manufacturer

Advantages of Registration

With a professional registration service team, we can customize product registration strategies for customers, avoid registration risks, and ensure timeliness of submitting registration applications;

With abundant evaluation resources, we can provide professional technical, regulatory and registration strategy suggestions;

Partners

There are more than 200 long-term partners, including more than 50 top 100 companies in the industry and more than 60 public companies.