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Regulatory affairs

Regulatory affairsStarting a clinical trial involves notifying it to applicable competent authorities (CAs) and ethics committees (ECs) for their information and, in some case for explicit written approval. The more efficiently this start-up process is carried out, the sooner countries and sites can be activated and patients be enrolled. Being familiar with the different regulations, agencies, practices and procedures in different countries is a distinct advantage.

SMS-oncology can navigate this complex regulatory landscape and ensure the submission approval process runs efficiently. Beyond submissions, we are skilled to advise our clients on the associated regulatory landscape in Europe and the USA to seize opportunities, anticipate to challenges, and circumvent possible hurdles.

SMS-oncology has overseen the drafting of several Investigational Medicinal Product Dossiers (IMPD) and Investigational New Drug (IND) applications, as well as Marketing Authorisation Applications (MAA). We have been involved in related interactions with Competent / Regulatory Authorities, at national and regional level (EMA/ FDA).

SMS-oncology’s team of start-up specialists and regulatory experts offer full support with respect to regulatory affairs and activities in the regulatory landscape.

Full regulatory affairs services
  • Providing regulatory support in relation to briefing packages, and attending scientific advice meetings with the FDA, EMA and other relevant authorities
  • Collection and preparation of essential documents
  • Obtaining Clinical Trial Applications (CTA) approvals from Competent Authorities (CA), Independent Ethics Committees (IEC), as well as local ECs and sites in a timely fashion
  • Submission and/or notification of substantial and non-substantial protocol amendments
  • Supporting our clients with accelerated approval opportunities, e.g. obtaining Orphan Drug Designation (ODD) or PRIME (PRIority Medicines) designation
  • Supporting our clients with compassionate use programs, early access and named patient programs

Cases studies


RFP or protocol advice?

Would you like to request a proposal (RFP), or interested in getting a free and confidential review of your planned early phase oncology trial (draft) protocol? Use the forms below:

Request for expert protocol advice (free) Request for proposal