Management consulting - designed for quality & regulatory.
Brightbark Cranberry integrates management consulting with our regulatory affairs consulting and training offerings to provide fully tailored solutions that grow your team’s capability, capacity, and confidence.
How can I get new product submissions through my regulatory team faster?
We recommend looking both inside your RA team, and beyond it. Whilst there are often opportunities for gains within RA teams - such as training, structure and clear responsibilities - they are also where the pain of technical debt is seen. We’ve written about this in our columns.
We have expertise from design & development, manufacturing, quality, regulatory and management, and bring this together to fully understand your business and process flows. The recommendations we make are bespoke to your organisation and your people - not straight out of a text book.
How can I give my regulatory team career growth?
Regulatory affairs staff remain in high demand, and can grow their careers quickly. If you cannot provide a structure for them to grow into, they will grow into roles elsewhere. We can help you keep your talent in house by building a tailored structure of progressive roles, with knowledge and experience for each role aligned with external benchmarks. This gives your team a clear route to career development, and gives you clear criteria for promotions.
OUR PEOPLE
Joseph Langley MEng CEng MTOPRA
Design - Manufacturing - Quality - Regulatory - Management
Underpinned by 7 years at a leading notified body.
“Standard management consulting is not specialist enough for quality and regulatory functions of med-tech companies. We have the niche expertise to grow your operational excellence.”
- Joseph Langley
REGULATORY MANAGEMENT CONSULTING
CONTRACT RESOURCE
REGULATORY AFFAIRS MANAGEMENT WITH NOTIFIED BODY KNOWLEDGE
FRACTIONAL LEADERSHIP
Most medical device start-ups reach a point where regulatory affairs can no longer be managed informally — but are not yet at the scale where a full-time senior hire makes commercial sense. A fractional Regulatory Affairs Manager provides the strategic direction and functional oversight the business needs at this stage, without the overhead of a permanent appointment.
From the earliest stages of product development, having experienced regulatory input shapes decisions that are difficult and costly to unpick later — classification, clinical strategy, the structure of your technical file, your choice of notified body. A fractional engagement brings that experience into the business on terms that fit where you are now, not where you will be in three years.
Interim or temporary management of teams, projects or portfolios.
Full time or part time.
Any duration.
