Regulatory Consultancy Services
Rose Pharma Solutions offers expert regulatory consultancy services led by a recent former EU Inspector and one of the very few accredited inspectors worldwide with specialist expertise in biological and advanced therapy medicinal products (ATMPs).
This unique regulatory background places Rose Pharma Solutions in an exceptional position to provide authoritative interpretation of current UK, EU, and international regulations, along with practical, inspection-informed guidance across biologicals, ATMPs, and other highly regulated pharmaceutical areas.
Our consultancy approach is grounded in real-world inspection experience, enabling clients to achieve compliance efficiently while reducing regulatory risk and inspection uncertainty.
Innovation Meetings
Rose Pharma Solutions provides specialist support for MHRA Innovation Office meetings, recognising that securing direct engagement with the Innovation Office is increasingly challenging for many organisations.
With extensive experience contributing to these meetings on GMP aspects of facility design, process design, and manufacturing strategy, we support clients in the development of new and innovative medicinal products. Our involvement helps ensure that regulatory expectations are clearly understood and that proposals are aligned with MHRA GMP requirements from the outset.
We work alongside your team to provide focused, inspection-informed input, helping you prepare for discussions and maximise the value of regulatory interactions.
Mock Regulatory Inspections
Rose Pharma Solutions delivers robust mock regulatory inspections designed to test your facilities, systems, and processes in a realistic yet supportive environment.
Led by experienced former regulators, our mock inspections replicate the depth, approach, and expectations of actual regulatory inspections, providing a credible challenge to your GMP and GDP compliance. We assess your operations against current MHRA, UK, EU, and international regulatory standards, identifying both strengths and potential gaps.
Following the inspection, we provide clear, practical guidance on remediation and improvement, helping you address identified gaps efficiently and strengthen inspection readiness with confidence.
For Cause & Supplier Audits
Rose Pharma Solutions provides for-cause and routine supplier audits designed to deliver meaningful insight and practical value, not just compliance checklists.
Drawing on unique regulatory and industry experience, our audits are focused, risk-based, and aligned with current GMP and GDP expectations. We help organisations gain a clear understanding of supplier performance, compliance risk, and quality system effectiveness, supporting informed decision-making and regulatory confidence. Our approach ensures that each audit delivers actionable outcomes, helping you address issues efficiently, strengthen supplier oversight, and maintain robust supply chain compliance.
Inspection Preparation & Remediation
Including Compliance Management & Inspection Action Group (IAG) Support - Rose Pharma Solutions provides end-to-end inspection preparation and remediation support, tailored to your organisation’s specific regulatory and operational needs.
We assist before, during, and after regulatory inspections, helping you prepare effectively, manage inspection interactions, and respond confidently to findings. With direct experience working within Compliance Management Teams and alongside the MHRA Inspection Action Group (IAG), we offer informed guidance on regulatory processes, expectations, and acceptable responses.
Our support is practical, proportionate, and inspection-focused, helping you address compliance issues efficiently and maintain constructive regulatory engagement.
In House Training & Coaching
Rose Pharma Solutions delivers high-quality in-house training and coaching, as well as public training courses, tailored to the needs of pharmaceutical, biotech, and advanced therapy organisations.
Our training is led by experienced former regulators and industry professionals, ensuring content is current, practical, and aligned with regulatory expectations. We focus on developing regulatory understanding, inspection readiness, and confident decision-making across quality, manufacturing, and compliance teams.
All training can be customised to your organisation, ensuring relevance, engagement, and immediate practical value.