Raw Materials for Medical Device

Many chemical companies produce polymers, additives, intermediates, co-formulations and new ingredients that can be used in the medical device and pharmaceutical industries. These chemicals not only need to comply with chemical regulations, but also need to comply with regulations for downstream applications.

If your product can be used for medical devices, pharmaceutical packaging materials or pharmaceutical excipients, we can help you evaluate your product regulatory obligations and provide product compliance requirements:

Related Services:

• Medical device raw materials master files submission
• Medical device raw materials master files change
• Pharmaceutical excipients submission
• Pharmaceutical packaging materials submission
• Safety evaluation of leachable materials