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Robert has worked in Med Device Regulatory Affairs for over 30 years, including orthopedic implants and cardiovascular devices. He specializes in Regulatory strategy, writing successful regulatory submissions, and negotiating with the FDA and EU Notified Bodies. He works as a consultant for small to midcap companies and is the President at Cadence Regulatory, LLC.
In this episode, Darwin and Robert discuss regulatory pathways, emphasizing key considerations for executives. Learn about strategic dos and don'ts to ensure a smooth journey through governing body's processes, preventing resource wastage and opportunity costs post-submission. Robert, with vast experience in successful submissions, sheds light on the crucial role regulatory plays in the C-Suite, influencing strategic decisions for growth and risk mitigation.
To contact Robert please visit www.CadenceRegulatory.com
#MarketAccess #FDAsubmissions #riskmitigation
Robert has worked in Med Device Regulatory Affairs for over 30 years, including orthopedic implants and cardiovascular devices. He specializes in Regulatory strategy, writing successful regulatory submissions, and negotiating with the FDA and EU Notified Bodies. He works as a consultant for small to midcap companies and is the President at Cadence Regulatory, LLC.
In this episode, Darwin and Robert discuss regulatory pathways, emphasizing key considerations for executives. Learn about strategic dos and don'ts to ensure a smooth journey through governing body's processes, preventing resource wastage and opportunity costs post-submission. Robert, with vast experience in successful submissions, sheds light on the crucial role regulatory plays in the C-Suite, influencing strategic decisions for growth and risk mitigation.
To contact Robert please visit www.CadenceRegulatory.com
#MarketAccess #FDAsubmissions #riskmitigation