Regulators across the world are trying to keep up to speed with new scientific insights, developments and research in food, pharmaceutical and especially the major advances in the biomedical field. This combined with an increasing globalization and market diversification brings along quite some regulatory challenges both for authorities as for the industry bringing products to the market.
To secure full compliance and anticipate on upcoming and changing regulations, Rousselot has a dedicated team in place. The team consists of a global network of regulatory affairs experts with local knowledge. To keep in step with changing regulations, we are actively participating in associations across the globe such as gelatin Manufacturers associations (GME , GMIA, SAGMA, GMAP), IPEC (International Pharmaceutical Excipient Council) and several more regional based associations.
By staying on top of current and upcoming regulations and guidelines we are able to provide you with proper regulatory information regarding our high quality products, manufactured according to up-to-date standards. The regulatory support Rousselot provides can help minimize product development time and accelerate product approval. As one-size-never-fits-all we are ready to support your specific regulatory needs and are able to comply with the most stringent safety and quality specifications required for emerging biomedical applications.
- Quality documentation according to recognized international standards confirming compliance to applicable regulations and guidelines.
- Certifications and adequate licensing
- Assistance on local import requirements to facilitate easy and fast delivery times
- Submission of Drug Master Files (Type IV (excipient) DMF or MAF (Device Master File) in US, excipient DMF in China) allowing submission of confidential information to local authorities and facilitating your product approval process.
- A product information package giving a full set of regulatory compliance on the specific product.
- Confirmation of compliance to specific requirement per market, such as for example viral inactivation studies and extended traceability for biomedical applications