Regulatory support

Icon, clinical trials in central & easter europe

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 biosample management
  • Regional regulatory consultation
  • Regulatory strategy and clinical development planning

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 international regulatory requirements is perhaps the greatest challenge.

Cromos Pharma has deep regulatory knowledge, experience, and skills that provide an invaluable asset for clients wishing to conduct clinical research in a variety of jurisdictions. Our Regulatory Department operates in accordance with the relevant FDA and EMA Directives and national regulatory requirements across all countries of our geographical coverage.

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 comparable medical standards of care.

Our team has almost two decades of experience in regulatory submissions for innovative biotherapeutics, cell therapies, antibody drug conjugates, immuno-oncology, as well as in complex generics, biosimilars, and other follow-on drugs.

Our regulatory affairs professionals have in-depth knowledge of national legislation and work with regulatory agencies (RA) and ethics committees (EC) in multiple jurisdictions within North America, Central and Eastern Europe (Bulgaria, Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Romania, Serbia, Slovakia, Slovenia, Ukraine), Eurasian region (Georgia, Armenia, Moldova), Western and Central Asia (Kazakhstan, Türkiye, Uzbekistan).

We have comprehensive knowledge and experience with the applicable local regulatory documents, requirements and approval procedures for FDA, EMA, Non-EU countries, including expertise in the procedures and activities required for the efficient import/export of APIs and medicines and a deep and localized knowledge of the relevant mechanisms for Regulatory Authorities (RA) and Ethics committee (EC) document submission.

We are committed to diligent preparation of all documents for RA and EC submissions. We make sure that regulatory approval procedures managed by our team run smoothly and without delays.

The company’s duty is to deliver studies and all related clinical activities in accordance with Cromos Pharma’s SOPs and Working Instructions unless the clients wish for Cromos to operate under their SOPs.

Our team of highly qualified regulatory professionals provides regulatory support throughout all stages of clinical research, starting from the process of developing the Study Protocol through to the Final Study Report.

Cromos Pharma has over 18 years of experience in managing all aspects of clinical trials across a range of therapeutic areas. With operations in the US, Central and Eastern Europe we combine global expertise with profound local market knowledge to deliver end to end solutions supporting our pharma and biotech clients.