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Core competencies
Our DMF documentation for all products is meticulously prepared to comply with the latest standards set by EDQM (CEP), ICH (ASMF in eCTD format), and FDA (US DMF). We conduct material and product testing in accordance with the European and United States Pharmacopeias, ensuring the highest quality and regulatory compliance.
We provide
professional support related to technology, analytical and special services.
We collaborate
closely with you in order to search for and suggest solutions on a day-to-day basis working in parallel with your technicians and analysts to offer the best solutions along the way.
We support
and help you to overcome challenges during your formulation development through solutions tailored to your needs.
Quality harmonization
We adhere to the highest quality standards that meet global requirements. Our robust and validated quality system enables you to significantly reduce your QC testing efforts while ensuring reliability and compliance.
Our core competencies form a strong foundation for ensuring customer satisfaction through the highest quality products delivered via environmentally friendly processes. At our FDA-approved facility in Central Europe, we offer comprehensive end-to-end solutions that encompass API development to scale-up. This allows for seamless process transfer to commercial-scale manufacturing, supported by world-class regulatory expertise.
Our highly qualified experts guarantees that the quality of our products is upheld at every stage of the production process. We strictly adhere to cGMP procedures and maintain comprehensive documentation through well-defined SOPs. Additionally, our state-of-the-art quality control laboratory ensures that the APIs produced by Polpharma consistently meet the highest quality standards.
QC testing according to both Ph. Eur. and USP monographs
We provide you with one batch which has been certified in accordance with the US and the Ph. Eur. Pharmacopeias based on your request. This will allow you to use this batch for whichever market, according to your needs.
Live Digital Tour at our API Plant
Visit us from anywhere!
We provide remote solutions for visits, audits, and ongoing project follow-ups, utilizing cutting-edge virtual conference technologies. Experience a customized live tour of our main API facility located in Starogard Gdański, Poland, tailored to your specific needs.
Inspections & Audits
Polpharma has EU GMP certificates for all production departments and all API
products.
*MPI - Main Pharmaceutical Inspectorate
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US FDA
Polish MPI
Polish MPI
Polish MPI
ANVISA Inspection
Polish MPI
Quality & compliance
- Documentation in an eCTD format and CEP certificates
- Specifications for every stage of production
- Qualification and audits of suppliers
- Quick response to complaints
- System procedures
- Compliance with cGMP
- On-the-job GMP training
- Validation and qualifications of equipment and production processes
