Press release
PANATecs has formed a strategic alliance with HWI ANALYTIK GmbH
Since the start of this year, PANATecs GmbH has had a strategic alliance with HWI ANALYTIK GmbH, headquartered in Rülzheim.
PANATecs GmbH is pleased to have HWI ANALYTIK GmbH as a cooperation partner with a complementary portfolio for the field of classical pharmaceutical products with chemically defined and botanical active substances.
HWI ANALYTIK GmbH was founded in 1991 and offers a large product portfolio of pharmaceutical services with its business areas of laboratory services, reference standards and drug safety.
In particular, the field of impurities analysis already offered by PANATecs GmbH in the portfolio is expanded by HWI ANALYTIK GmbH. HWI ANALYTIK GmbH is an ideal and experienced partner for the testing of extractables and leachables from primary packaging materials including closure systems which is stipulated in ICH Q6A and which must be performed for all newly developed medicinal products.
As part of a risk analysis, it is determined which packaging material components could come into contact with the product. Comprehensive screening for extractables with subsequent evaluation takes place. If necessary, leachable studies on the medicinal products are performed as a part of stability studies. All methods can, at the customer's request, be validated in a manner compliant with ICH.
About PANATecs:
PANATecs GmbH specializes in providing mass-spectrometry-based services for the pharmaceutical and biotech industries, and in manufacturing and selling bioanalytical substances (such as peptides, antibodies, marker reagents, etc.) for research purposes.
PANATecs has been awarded the ISO 9001 Certificate. The company possesses manufacturing authorization for test laboratories in accordance with §13 of the 15th Amendment of the Medicines Act.
PANATecs GmbH
Inselwiesenstr. 10
D-74076 Heilbronn
www.panatecs.com
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