Beijing Kairuike De Pharmaceutical Technology Research Co., Ltd. (hereinafter referred to as “the Company”) was established in July 2008 by a team of senior experts long engaged in drug research and registration submissions for the U.S., Europe and China. It is a full-service CRO specializing in pharmaceutical R&D and compliance services. Since its establishment, the Company’s core team has undertaken the preparation of registration dossiers for pharmaceutical products targeting European and American markets and provided GMP compliance guidance. Its business has gradually expanded to registration submissions in countries along the Belt and Road, helping Chinese pharmaceutical enterprises explore global development space beyond mainstream markets.

The Company focuses on the core links of international drug registration and quality research. It has established an analytical testing center with fixed-asset investment exceeding RMB 50 million, equipped with a full range of pharmacopoeia-compliant testing instruments including ultra-high-performance liquid chromatography (UHPLC), HPLC, GC, ion chromatography, high-resolution mass spectrometry, LC-MS/GC-MS, X-ray diffractometer, ICP, etc. More than 30 analytical engineers have completed over 1,000 method development and validation projects. The Company has set up European Pharmacopoeia compliance strategic consulting centers in China and France, and is currently a compliance partner of the European Pharmacopoeia (Ph. Eur.).

Over the past forteen years, the Company has assisted clients in completing more than 500 overseas registration submissions and guided over 80 on-site inspections by FDA, EDQM, WHO, TGA, KFDA, Brazil ANVISA and China’s “Three-in-One” inspections, including 6 zero-deficiency FDA certifications and 1 zero-deficiency EDQM inspection. The analytical testing center has obtained ISO 9001 and CNAS certifications, routinely implements OMCL standards, and is ready to accept official inspections from domestic and international authorities as well as client audits at any time.

Core Expert Resource: Technical Expert of the European Pharmacopoeia Commission – Kou Guotong

Mr. Kou Guotong: Legal Representative, Executive Director and General Manager of the company. He is a Technical Expert of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and a member of the drafting group for EP 12.0.

As the founder and Technical Director of Shijiazhuang Kairuide Pharmaceutical Technology Development Co., Ltd., he brings nearly twenty years of experience in drug research, clinical studies and regulatory submissions. He has been selected into the expert databases for U.S. FDA drug submissions and European drug submissions.

He has strategic collaboration experience with well-known domestic and international CROs, and has executed monitoring and auditing projects for international multi-center clinical trials, building compliance teams under GLP, GCP and GMP-like standards.

He has led the completion of dozens of projects including U.S. ANDA, 505(b)(2) new dosage form modifications, OTC drugs, ICH-compliant studies for APIs, and domestic generic drug consistency evaluations. He has organized the R&D and submission of more than thirty solid/liquid dosage form generic drugs and over twenty deficiency response studies, and has repeatedly participated as a technical expert in FDA Pre-Approval Inspections (PAI) and on-site inspections by the National Medical Products Administration (NMPA).

In 2024–2025, Mr. Kou Guotong serves as Chief Expert of the Pharmaceutical Excipients Branch of the China Chamber of Commerce for Import and Export of Medicines and Health Products. He has been continuously invited to deliver keynote speeches at national industry platforms such as the inauguration ceremony of the Pharmaceutical Excipients Branch of the Chamber of Commerce and the CPHI China Pharmaceutical Excipients Internationalization Salon. He is one of the few authoritative experts in China with full-lifecycle practical experience spanning “pharmacopoeia drafting – registration submission – on-site inspection” for innovative drugs.