Göttingen, Germany — January 9, 2026 — gempex Consulting has entered into a strategic collaboration with NextPharma, a leading European contract development and manufacturing organization (CDMO) and authorized importer of medicinal products (Importer). Together, the two organizations will provide integrated, end-to-end solutions that are fully compliant with both EU and Chinese regulatory requirements. These solutions support Chinese biopharmaceutical companies across the entire product lifecycle, from preclinical and clinical development to regulatory submissions, commercial manufacturing, and market access.
This partnership follows a specialized seminar held jointly at the NextPharma facility in Göttingen, Germany, on January 7–8, 2026. Mr. Ralf Gengenbach, Founder and General Manager of gempex Consulting, and Ms. Tracy Feng, Deputy General Manager, met with NextPharma’s core teams from clinical supply, analytical and laboratory testing, commercial production, global distribution and warehousing, project management, and Qualified Person (QP) services. Together, they conducted in-depth discussions on market demand, compliance pathways, and collaboration models for Chinese biopharmaceuticals entering the European market.
A Powerful Partnership to Strengthen Key Capabilities for Chinese Pharma Global Expansion
gempex brings 24 years of pharmaceutical industry experience and is dedicated to helping life sciences companies worldwide meet international GMP standards. Its China team has deep roots in the local market and a thorough understanding of the transformation challenges Chinese biopharma companies face—from R&D innovation to global expansion—particularly in strategic planning and compliance implementation for product transfers between China and Europe.
As a well-established European CDMO, NextPharma operates 10 production sites, 5 logistics centers, and employs more than 2,400 people. Its services span the entire product lifecycle, including formulation/process development, analytical services, clinical supply (covering IMP manufacturing, packaging, labeling, and global distribution), and commercial manufacturing. NextPharma also holds expertise in specialized technology areas such as high-potency drugs, antibiotics, and ophthalmic preparations.
Through this collaboration, gempex’s expertise in international market access strategy, compliance auditing, EU QP audit and product release, and marketing authorization will be combined with NextPharma’s operational strengths in clinical trial supply chain management, testing and release, commercial supply, warehousing and logistics, and global distribution. Together, they are building a seamless “China–Europe Biopharmaceutical Bridge.”
Service Upgrade: Comprehensive Support from Compliance Strategy to Physical Delivery
This collaboration marks a significant enhancement of gempex Consulting’s service offerings. Going forward, the two partners will deliver integrated service solutions to Chinese biotech firms, pharmaceutical companies, and Marketing Authorization Holders (MAHs), including but not limited to:
Strategic & Compliance Planning: Product positioning strategy, GMP compliance gap analysis, quality system establishment, QP audit and release support.
Clinical-Stage Support: Import, packaging, labeling, storage, and global supply chain management of investigational medicinal products (IMPs).
Commercialization Support: Technology transfer, process validation, commercial manufacturing, secondary packaging, and warehousing and distribution services across the EU and global markets.
Ongoing Quality Oversight: Serving as the client’s external quality office to conduct continuous audits and supervision of CMOs/CDMOs, ensuring sustained compliance.
Focusing on the Future, Expanding Globally Together
This partnership is designed to precisely connect the overseas expansion needs of Chinese innovative drugs with Europe’s high-standard supply chain and compliance resources, helping Chinese biopharmaceutical products enter the EU and global markets more efficiently and robustly.
Ms. Tracy Feng, Deputy General Manager of gempex Consulting, commented, “The Chinese biopharmaceutical industry is at a critical intersection of innovation and globalization. Our partnership with NextPharma goes beyond offering solutions—it is about building a sustainable and trusted ecosystem that enables Chinese innovations to connect more smoothly with global standards and markets.”
This strategic collaboration reflects gempex Consulting’s long-standing commitment to being the most trusted international compliance partner for its clients. gempex and NextPharma have established a dedicated communication mechanism to fully support Chinese innovations on their journey toward the global market with greater stability.
To learn more about GMP-related insights, visit www.gempexchina.com/gmp-knowledge for further information on GMP services offered by gempex Consulting.
For specific compliance inquiries, please contact us via:
Hotline: 400 166 2002
Email: info-cn@gempex.com
About gempex Consulting
With over 23 years of deep specialization in GMP compliance, gempex Consulting is committed to providing global life science enterprises with compliant, efficient, and executable GMP solutions. We support a wide range of sectors, including pharmaceuticals, biotechnology, APIs, chemicals, medical devices, primary and secondary packaging materials, and cosmetics in meeting GMP standards and reducing compliance and drug safety risks.
Our team comprises more than 60 experienced GMP experts. We have successfully delivered over 5,000 projects worldwide and served more than 1,000 clients. Our global reach spans more than 20 countries, and we maintain long-term cooperative relationships with many renowned pharmaceutical companies.
