Biologicals

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Biologicals

Using our expertise in biological regulatory affairs and lifecycle management (LCM), we are capable of providing the needed biologics regulatory services for marketing authorizations and LCM support for a variety of biological products on the global market.

Oraculum’s biologics regulatory affairs personnel have vast experience in every aspect of product development, from initial product development to clinical studies, marketing authorisation, and post-approval lifecycle management. In today’s global economy, understanding regulatory standards in the proper way can save a company time, effort, and money. Oraculum’s team of biologics regulatory affairs professionals includes industry experts and former regulatory agency employees with over 25 years of experience.

There are many types of biological therapeutic products, however here are a few examples:
  • Vaccines (for example, DTP vaccine, MMR vaccine, HPV vaccine, PCV vaccine, Typhoid vaccine, Polio vaccine & Hepatitis B vaccine)
  • Recombinant therapeutic proteins and monoclonal antibodies (for example, GCSF, Erythropoietin, Insulin, Infliximab, Etanercept, Bevacizumab, Rituximab, etc.)
  • Blood and sera products (for example, human immunoglobulins, anti-snake venom, anti-tetanus toxin sera, anti-diphtheria toxin sera, etc.)
  • Cellular and gene therapy products (for example, Cord blood products and genetically modified viral therapies)