SubscribeRecognized as a world leader in the development chemistry market, quality lies at the heart of all that we do at CarboGen and AMCIS. Our state-of-the-art facilities operate to the highest standards of Good Laboratory Practice (cGLP) and Good Manufacturing Practice (cGMP).
Quality management at CarboGen and AMCIS includes a comprehensive series of organizational structure, procedures, processes and resources, as well as the activities necessary to ensure confidence that the APIs we produce will meet intended specifications for quality and purity.
The process involves the active participation of management and appropriate team members and ensures that all quality-related activities are well defined and documented.
Our quality management system has been developed on the basis of the Q7A guidelines of the International Conference on Harmonisation (ICH) and in accordance with the 9001:2000 standards of the International Organization for Standardization (ISO).
Regulatory Affairs
Experienced in both drug substance development and commercial-scale production, CarboGen and AMCIS offer a broad regulatory perspective. Our work spans the entire drug development process supporting customers from Investigational New Drug Application (IND), through New Drug Application (NDA), to in-market supply.
CarboGen and AMCIS offer deep knowledge of all relevant international guidelines, regulations and pharmacopoeias and also commit to stay at the forefront of evolving regulations by working closely with regulatory agencies and industry association groups.
Regulatory Documentation Preparation
CarboGen and AMCIS help our clients proceed through the regulatory filing processes by providing full support in the preparation of regulatory documentation (including in Common Technical Document format). In this process, we assist with each of the following:
Chemistry, manufacturing, and control documentation to support:
- Investigational New Drug Applications (INDs)
- Investigational Medicinal Product Dossiers (IMPDs)
- New Drug Applications (NDAs)
- Marketing Authorization Applications (MAAs)
- Post-approval change documentation
- Type II Drug Master Files (DMFs)
- European Drug Master Files (EDMFs)
Regulatory Management
Beyond the preparation of regulatory documentation, CarboGen and AMCIS ensure regulatory compliance along the drug development pathway and throughout commercialization. We provide regulatory guidance throughout process development and launch strategies and ensure compliance in activities such as: Change Control, Specifications, Process Validation, Analytical Validation.
Third-party Auditing
The nature of the project or our clients’ development strategy frequently requires that we coordinate work with other third parties, such as raw material suppliers or analytical chemistry laboratories. In this case, we provide auditing services to offer a clear picture of the quality level of all parties involved in the project.