Regulatory Affairs
Experienced in both drug substance development and commercial-scale production, CARBOGEN AMCIS is supporting customers from Investigational New Drug Application (IND), through New Drug Application (NDA), to in-market supply.
CARBOGEN AMCIS offers deep knowledge of all relevant international guidelines, regulations and pharmacopoeias and also commit to stay at the forefront of the evolving regulations by working closely with regulatory agencies and industry association groups.
Regulatory Documentation Preparation
CARBOGEN AMCIS helps its 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) for US
- Investigational Medicinal Product Dossiers (IMPDs) for EU
- New Drug Applications (NDAs)
- Marketing Authorization Applications (MAAs)
- Post-approval change documentation
- Drug Master Files (DMFs) for US, EU, Japan, Canada, Australia, New Zealand.
- Certificate of Suitability of the European Pharmacopoeia (CEP)
Regulatory Management
Beyond the preparation of regulatory documentation, CARBOGEN AMCIS ensure regulatory compliance along the drug development pathway and throughout commercialization. We provide regulatory guidance in the elaboration of the process development and launch strategies and ensure compliance in activities such as:
- Change control
- Specifications
- Process validation
- Analytical validation
