Quality & Regulatory

Quality & Regulatory

Quality, the extent to which a product or service fulfills defined requirements, is important in every relationship between companies. In the pharmaceutical business and other related areas, it is essential, as quality defects can put patients at risk. We at Bachem are fully committed to always delivering optimal quality. Embedded as a strategy and established as a company-wide mission, it defines our day-to-day activities in all departments involved.

We consistently comply with Good Manufacturing Practices (GMP), as regulated by Swiss national, EU, US, and Japanese laws. Inspections by national authorities as well as audits by customers with successful outcome, are proof of our GMP and GDP (Good Distribution Practices) compliance. With half a century of experience, we are thrilled to offer our customers end-to-end partnership in commercialization of the respective drug substance: from pre-clinical and clinical development through worldwide marketing authorization.

Together with you we work on overcoming regulatory challenges and on finding the best regulatory strategy for your product not only for commercial applications but also during clinical development. We offer compilation of API dossiers based on experience and according to your needs for each life cycle phase.

For peptides and oligonucleotides Bachem offers a wide range of API services including process and analytical development, stability studies, impurity identification, as well as the provision of reference standards. With more than 20% of our workforce engaged in quality assurance, quality control and regulatory affairs, we support wherever needed. Quality Matters at Bachem.

We are experienced in writing different types of regulatory dossiers, such as CMC documentation for clinical trial applications, Drug Master Files and dossiers for CEP applications:

Drug Master Files (DMF)

Drug Master Files DMF compiled by Bachem contain the relevant details of the chemistry, manufacture and control for an API enabling competent authorities (e.g. EMA and FDA) to review process information in support of third party drug product marketing applications.

Bachem will provide a letter of authorization/access that will allow the relevant authorities to review and assess the DMF.

In addition to compiling and filing Drug Substance regulatory documents in Europe, United States, and Japan, Bachem has also a broad regulatory experience throughout the world.

Certificates of suitability (CEP)

The role of a Certificate of Suitability (CEP) is to certify the compliance of a material with the requirements laid down in the relevant monograph of the European Pharmacopoeia. CEP can be referenced in a Clinical Trial Application as well as in a Marketing Authorization Application instead of a Drug Master File.

Bachem has been granted a CEP by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) for the following API:

Official Licenses and certificates

The Bachem facilities are regularly inspected and approved by national and international regulatory authorities like FDA, Swissmedic and others. The following list shows the most important documents which have been granted to Bachem from various authorities.

 

Manufacturing Licenses:

Certificates of GMP Compliance:

Japanese Accreditation as Foreign Manufacturer:

ISO certificate:

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