Pharmaceutical

As a recognized leader in the industry, our company provides solutions at all key stages of the drug lifecycle to help our clients gain regulatory approval faster.

The quality of pharmaceuticals directly affects the lives of patients. Pharmaceutical companies should engage in drug production and business operations in accordance with the relevant national and industry quality requirements to ensure drug safety and provide society with high-quality, safe, and healthy products and services.

As a leader in the pharmaceutical and healthcare industry, our company attaches great importance to the quality of pharmaceuticals. Our state-of-the-art facilities, rigorous testing, specialized technical and analytical capabilities, and standardized inspections allow us to provide strong support to the pharmaceutical and biotechnology industries worldwide that are developing and producing novel drugs and related healthcare products.

In the past few years, our company has explored and made achievements in the field of compliance technologies for APIs, innovative drugs， and pharmaceutical packaging materials. Our service areas cover the research and development, production, operation, and import and export of pharmaceutical companies, helping these companies to achieve closed-loop control of the whole process of compliance and access to global target markets.

Our Services in the Pharmaceutical Industry

Combining experts who are familiar with drug-related regulations in various countries and regions, and testing laboratories with advanced technology, our company has the strength to provide professional and customizable drug regulatory compliance services with professional technology and testing capabilities. Our services include bioanalysis of large and small molecule drugs, as well as a variety of analytical research programs to support all phases of drug development from inception to production. Our services include but not limited to:

China

• China Drug Product Registration
• China Pharmaceutical Excipient Registration
• China API Registration
• China Pharmaceutical Packaging Registration

Europe & Americas

• U.S. Abbreviated New Drug Application (ANDA)
• U.S. Investigational New Drug (IND) Application
• EU Active Substance Master File (ASMF) Production
• U.S. New Drug Application (NDA)
• EU Marketing Authorisation Application (MAA)
• U.S. Drug Master File Document Production and Filing
• EU Traditional Herbal Registration (THR)

Highthink eCTD Filing System

Industry Solutions

• Pharmaceutical regulatory consulting solutions for innovator/brand-name drugs and generic drugs
• Pharmaceutical regulatory consulting solutions for prescription drugs and over-the-counter (OTC) drugs

Technical Service Capability

As a science-based consulting firm, Our company provides regulatory and scientific advice to clients in the pharmaceutical field, from the pre-clinical stage through the marketing and post-approval phases. Our thorough understanding and extensive experience of pharmaceutical regulations help you determine the most effective drug development and registration pathway in a timely manner. If you need help or have a question, please feel free to contact us for more details.