Regulatory

DSM Pharmaceutical Products has a successful track record built on a strong foundation of expertise in the areas of compliance, regulatory understanding and foresight.

Whether you’re interested in biopharmaceutical or pharmaceutical custom manufacturing services, we have the experience to take your molecule from post-discovery to commercial launch on schedule in a seamless approach that delivers your product ahead of the competition.

► Preparation of submission-ready CMC documentation in multiple formats to include: INDs, CTXs, NDAs, MAAs, BLAs, ANDAs, NDSs, DMFs and SNDAs for site transfers.

► Technical and regulatory review of all documentation to support regulatory submissions to include date interpretation.

► Development of CMC strategies

► Transfer of documentation

► Extensive experience and solid relationships with agencies including:

– Code of Federal Regulations

– United States Pharmacopoeia

– British Pharmacopoeia

– European Pharmacopoeia

– Japanese Pharmacopoeia

Our internal requirements reflect the most stringent regulatory requirements mandated internationally. So when it’s time for approval of your product, DSM’s regulatory procedures mean your product will meet, or more often, exceed what a government regulatory agency requires.