Who We Are
Bespoke Quality & Compliance is a boutique consulting firm supporting emerging biotechs with pragmatic, inspection-ready quality system, GCP compliance strategy, and regulatory alignment across global clinical programs.
We operate as a lean, modern partner - combining deep clinical quality experience with the agility required to support rapidly evolving research and breakthrough technologies.
Our practice is powered by a core leadership team with over a decade of hands-on experience building inspection-ready, risk-based quality systems, leading global trials, and supporting regulatory submissions across the US, UK, EU, and Australia. We also partner with a trusted network of seasoned specialists in clinical operations, medical writing, regulatory strategy, information technology to provide clients with comprehensive end-to-end support.
Our Story
Bespoke Quality & Compliance was founded on a simple belief:
Innovation deserves infrastructure.
Every breakthrough therapy, every first-in-human study, every pioneering platform needs a quality and compliance foundation strong enough to support it.
With nearly a decade in clinical quality leadership roles our founder, Bhavika Paradis, has partnered closely with biotech start-ups, research teams, CROs, and therapeutic innovators across the world. Over the years, she has seen how the most promising science can stall - not because of the idea, but because of gaps in processes, documentation, oversight, and regulatory readiness.
Bhavika created Bespoke Quality & Compliance to change that.
Our Philosophy
We believe that great quality systems are:
Lean, scalable, and right-sized Not bloated with unnecessary procedures or legacy bureaucracy.
Inspection-ready by design So teams can operate with confidence, not scramble at the last minute.
Rooted in patient-safety Because every data point represents a real human story
Informed by innovation Regulations are essential, but innovation often outpaces regulatory frameworks. We help emerging biotechs navigate, interpret, and even shape the regulatory landscape so they can innovate responsibly and advocate for needed change.
