Regulatory support
Do you need regulatory data or additional studies?
Do you have a qualification questionnaire to fill in?
Would you like to carry out a document quality assessment?
Our Regulatory Support is at your disposal.
Regulatory support
We know how important it is to provide information to help our customers meet regulatory requirements.
All our components, products and single-use assemblies are delivered with all the necessary documentation and regulatory support.
We ensure that the components we purchase meet the specific requirements of the biopharmaceutical industry and that they come from qualified suppliers. To achieve this, we work closely with our suppliers and implement a rigorous supplier qualification and monitoring process, including supplier audits for critical components.
Documentation
All our components are subject to an initial review to ensure they meet regulatory standards. We can provide you with:
- validation files for most of our components and single-use made-to-measure assemblies
- different types of studies (extractable, releasable, etc.)
- a Regulatory Information Overview (RIO) document on request
- various types of certificate on request (Nitrosamine, latex, phthalates, etc.)
Certificates of conformity
Certificates of conformity are systematically enclosed with the product or Single-Use assembly in the parcel we deliver to you.
We’ve created a secure personal Customer Area for you. Once you have created your account, you can retrieve all your certificates of conformity with a single click, in complete autonomy.
Contact our teams to find out more
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FAQ
These biomanufacturing studies are scientific analyses aimed at identifying and quantifying the chemical substances that can be extracted from a material when it is exposed to specific conditions, as well as the chemical substances that actually migrate from a material or component in direct contact with the biopharmaceutical product, under normal conditions of use. These materials may include components used in biomanufacturing equipment, such as chromatography resins, cell culture bags, tubing, filters or storage systems.
These studies are essential in bioproduction for :
- Patient safety: biopharmaceutical products are often administered directly to patients, making it essential to control potential contaminants.
- Product quality: extractives can interact with the biopharmaceutical product and alter its stability or efficacy.
- Regulatory compliance: agencies require extractives data to approve materials used in manufacturing processes.
These studies identify :
- List of compounds identified (e.g. plasticisers, additives, stabilisers, manufacturing residues).
- Maximum concentrations of compounds under extreme conditions.
- Toxicological risk assessment for identified compounds.
These studies are a crucial step in guaranteeing the safety, quality and conformity of biopharmaceutical products throughout their production cycle.