Bioregulatory Consulting (BRC) is based in Melbourne, Australia and has provided a specialised regulatory and development consultancy service to the biotech and pharmaceutical industry since 2002.
Penny Field, as the Principal Consultant of Bioregulatory Consulting, has consulted on the regulatory strategy and development of monoclonal antibodies, immunotherapeutics, recombinant proteins, gene therapies and biosimilars. Penny has written Investigational New Drug (IND) Applications, Clinical Trial Exemptions (CTX) and Marketing Applications for recombinant proteins, vaccines, NCE, generics and blood products.
If you are interested in an independent and confidential review of your regulatory strategy and drug development program, Penny Field will be available at the BioMelbourne Network offices on Tuesday 19 April for a Regulatory Clinic. Sessions are of 45 minutes duration. Confidentiality Agreements can be organised prior to the event to assist with confidential discussions. Please note that the provision of briefing package, prior to the event, would aid discussions on the day.
Please note this event is fully booked but please contact Vicky Jones at BioMelbourne if you wish to be put in contact with Bioregulatory Consulting (BRC).