Regulatory Affairs
Senior regulatory expertise for SMEs and R&D organisations in the pharmaceutical, veterinary, crop protection and biocide sectors, on a project, interim or advisory basis.
If any of these situations sounds familiar, you're in the right place:
- You need senior regulatory expertise without building a full in-house team.
- You are running a development programme, a lifecycle extension or an authorisation procedure, and you need a partner who understands both the science and the regulatory system.
- Tracking what EMA, EFSA, ECHA and national authorities are doing is consuming time your team does not have.
- You are building or transforming a regulatory function after a merger, a restructuring or a strategic shift that changed what regulatory needs to deliver.
Regulatory Affairs support
I write and review regulatory dossiers, manage authorisation procedures and lifecycle activities, and track regulatory intelligence across the authorities that matter to your product: EMA, EFSA, ECHA and national competent authorities.
- Dossier writing and compilation
- Critical summaries and expert statements
- Planning and managing procedures
- Geographical and line extensions
- R&D, marketing and business development support
- RA and business intelligence (AI driven, Open EFSA)
Sectors: pharma, veterinary medicines, crop protection and biocides.
The result: regulatory work done right, without the overhead of a full in-house team.
Organisational development
For leaders who know that regulatory capability is a strategic asset, and want to build it deliberately.
I design and deliver coaching, mentoring and training programmes for regulatory and R&D professionals. I help organisations map, redesign and improve regulatory processes. And I develop personal development plans and team curricula that build tacit knowledge, not just procedural compliance.
- RA coaching and mentoring, from someone who has actually been inside the industry
- Process mapping and redesign for RA teams that work in silos
- Training courses on regulatory affairs, compliance and regulatory intelligence
The result: a regulatory function that learns, adapts and leads, not one that merely keeps up.
Courses and workshops
- Regulatory Affairs Basic Course: five live webinars on EU market access for pharmaceuticals, plant protection products and medical devices, with case studies
- Regulatory Affairs Essentials (Pharma): video course for career starters in pharma
- Business Kick Start Workshop: Foundation Edition: three remote modules for start-ups in pharma, biotech and chemicals, from Business Model Canvas to a mentor-led roadmap
- Business Kick Start Workshop: Extended Edition: the three foundation modules plus an individual 3-hour deep dive, with three mentors
Looking for AI training for your R&D team? See AI for R&D.
