pharmabio consulting

Drug Development

Proteins | Monoclonal Antibodies MAbs | Growth Factors | Hormones | Fusion Proteins | Cytokines | Therapeutic Enzymes | Recombinant Vaccines | Stem cells | Blood Factors | Anticoagulants, Other Innovator Biologics, New Drug Delivery Systems, Drug/Biologic or Device/ Biologic Small molecule new chemical/molecular entities (NCEs/NMEs) | Combination Products: drug/drug, drug/biologic, drug/device, biologic/device | Biosimilars | Follow-on Biologics Similar or Improved Versions of Originator Biopharmaceutical Products |

The PHARMABIO Team conducts Due Deligence of drug development or drug licencing candidates, clinical trial design, project management, and scientific and regulatory writing. This includes clinical protocol development, ICH clinical report writing, regulatory submissions, manuscripts, clinical study management, as well as technical QA and QC audits.

Biotech Consulting

PHARMABIO Consulting excels in the development of BIOSIMILAR MEDICINES, staff having led the first biosimilars approvals on the EU market 2006-2015.  It is also active in implementing the Biologics Price Competition and Innovation Act (BPCI) passed by the US Senate in 2009/2010, under a 351k Abbreviated-BLA pathway.

PHARMABIO Consulting provides expertise covering all key disciplines, having regulatory experts including former FDA and EU regulators, statisticians, clinical pharmacology and clinical efficacy/safety and pharmaceutical experienced consultants. With global strategy in mind, we can help you with a comprehensive, program for the selection, development and approval of any type of biosimilar product, any where in the world.

Our services for drug development include:

PIPs

PIPs

Your experts in Drug Development and Global Regulatory Affairs.