A gateway to the EU market for Chinese pharmaceutical companies.
CDMO Services Powered by the NEUCA Group is a combination of knowledge, experience and facilities of four companies: EWA, Global Pharma CM, Synoptis Industrial and NEUCA. With the synergy of our expertise, we offer comprehensive support in the field of Contract Manufacturing and services in accordance with GMP and GDP standards.
We are an expert in processes related to the import and quality control of products launched onto the markets of the European Union. We handle the comprehensive import of pharmaceutical raw materials, medicinal products, and medical devices. We provide complex support, from obtaining the required licenses, including for controlled drugs, to managing the cold chain. We offer customs clearance, VAT settlement, and transport from ports and airports to our import warehouses, where products await release for circulation within the EU. We own two GMP-certified laboratories. We perform analytical method transfers (AMT) and a full range of quality tests for
medicinal products. We use both modern analytical technologies
and pharmacopoeial or dedicated methods, which guarantees that each
batch complies with the registration documentation. We have advanced
testing equipment at our disposal for: inhalation
products, tablets, ointments, pharmaceutical raw materials, heavy metal
and nitrosamine content. Batch certification is carried out by qualified QPs who confirm that
the product complies with the requirements of the specification,
GMP standards and EU regulations. Our specialists conduct manufacturer
audits, oversee the documentation process, and are responsible
for issuing a marketing authorization certificate valid throughout the
European Union.
We offer also contract manufacturing for clients from 56 countries. We produce private-label dietary supplements, medical devices and medicines. We guarantee our clients safety, repeatability and full compliance with regulatory requirements.
