The drug development industry is now a global affair, with most biopharma companies seeking optimal ways to gain product approvals in the largest markets, which are often the most highly regulated venues. Navigating the slippery slope of international regulatory requirements is perhaps the greatest challenge. Cromos Pharma’s geographic and capability strategy is designed to accommodate such global requirements by combining regulatory expertise across the US and Europe, the most regulated venues, with geography that encompasses the highest enrolling venues, in countries with medical standards of care comparable to the West.

Our regulatory reach in North America spans both USFDA and Health Canada, and includes professionals experienced in all phases, from CMC and IND through interventional Phase I, II and III, to post-marketing, and pharmacovigilance studies. Our team has broad and deep experience ranging from innovative biotherapeutics, cell therapies, antibody drug conjugates and small molecule-centric immuno-oncology, to complex generics, biosimilars, and other follow-on drugs.

In the ex-US regulatory venues our regulatory affairs professionals have in-depth knowledge of national legislation, in addition to extensive clinical trials expertise in working with regulatory agencies (RA) and ethics committees (EC) in multiple jurisdictions within Eastern Europe (e.g. Czech Republic, Hungary, Latvia, Lithuania, Estonia, Poland, etc.) and ex-USSR (e.g. Belarus, Georgia, Russia, Ukraine, Moldova, Armenia, Kazakhstan, Uzbekistan). We are committed to diligent preparation of all documents for RA and EC submission and we make sure that regulatory approval procedures managed by our team run smoothly and without delays.

In all venues, we provide the following services:

  • Compilation of initial submissions, amendments, notifications, and closeout submissions to RA and ECs/IRBs
  • Customization/localization/review of informed consent documentation
  • Negotiation with insurance companies on compulsory trial subjects' insurance
  • Comprehensive regulatory support throughout the study
  • Obtaining of import/export licenses for the study drug and biosamples
  • Regional regulatory consultation
  • Regulatory strategy and clinical development planning

If you are interested in regulatory consulting or submission services provided by Cromos Pharma, please feel free to contact us.