GMP & Pharmaceutical Consultancy Services
Rose Pharma Solutions provides specialist pharmaceutical consultancy across GMP, GDP, regulatory compliance, quality systems and inspection readiness, supporting pharmaceutical, biotechnology and advanced therapy organisations across the UK, Europe and international markets.
Led by Philip Rose, an EU Qualified Person and former MHRA Lead Senior GMDP Inspector, our consultancy combines more than 25 years of pharmaceutical industry experience with direct regulatory inspection expertise.
This unique perspective allows us to provide practical, inspection-informed advice that helps organisations understand regulatory expectations, identify and address compliance risks, strengthen their quality systems and prepare confidently for regulatory engagement.
Whether you need specialist regulatory advice, an independent assessment of your systems, support preparing for an inspection or tailored GMP training, Rose Pharma Solutions provides experienced, proportionate and practical support built around your organisation's needs.
GMP & Regulatory Consultancy
Rose Pharma Solutions provides specialist GMP and regulatory consultancy led by a former EU Inspector and one of the very few accredited inspectors worldwide with specialist expertise in biological and advanced therapy medicinal products (ATMPs).
We provide expert advice across UK, EU and international regulatory requirements, helping organisations navigate complex regulatory challenges and make informed decisions throughout the product lifecycle.
Our consultancy covers GMP, GDP, quality systems, regulatory compliance and related pharmaceutical requirements, with support tailored to the specific needs and circumstances of each organisation.
Whether you are developing a new product or facility, addressing a compliance challenge or strengthening existing systems, we provide practical, independent and inspection-informed advice.
MHRA Innovation Office Support
Rose Pharma Solutions provides specialist support for MHRA Innovation Office meetings, helping organisations developing new and innovative medicinal products navigate the GMP considerations associated with their development and manufacturing strategies.
Our experience includes contributing to Innovation Office meetings covering GMP aspects of facility design, process design and manufacturing strategy, providing an informed perspective on regulatory expectations at an early stage.
We can support organisations in preparing for regulatory discussions, reviewing proposed approaches and identifying potential GMP challenges before they become significant issues.
Our practical, inspection-informed approach helps organisations make better-informed decisions and develop robust strategies as innovative medicinal products progress through development.
Mock MHRA & Regulatory Inspections
Rose Pharma Solutions provides mock MHRA and regulatory inspections designed to test your facilities, systems and processes in a realistic yet supportive environment before an actual inspection takes place.
Our mock inspections replicate the depth, approach and expectations of 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 areas of strength as well as potential compliance gaps and areas requiring further attention.
Following the inspection, we provide clear, practical feedback and recommendations to help your organisation understand its position, prioritise actions and strengthen overall inspection readiness.
GMP, GDP & Supplier Auditing
Rose Pharma Solutions provides GMP, GDP, for-cause and routine supplier audits designed to deliver meaningful insight and practical value, rather than simply working through compliance checklists.
Our audits are focused, risk-based and aligned with current GMP and GDP expectations, helping organisations assess supplier compliance, identify potential risks and maintain effective oversight of their pharmaceutical supply chain.
We look beyond documented procedures to understand how systems and processes operate in practice, providing an informed assessment of supplier performance and quality management.
Each audit provides clear findings and practical recommendations, helping organisations make informed decisions, address identified issues and strengthen supplier oversight.
MHRA Inspection Readiness & Remediation
Rose Pharma Solutions provides specialist MHRA inspection readiness, preparation and remediation support, tailored to your organisation's specific regulatory and operational needs.
We assist before, during and after regulatory inspections, helping organisations understand regulatory expectations, prepare effectively and respond appropriately to inspection findings.
Our experience includes working within Compliance Management Teams and alongside the MHRA Inspection Action Group (IAG), providing valuable insight into regulatory processes, expectations and acceptable responses.
We can support inspection readiness assessments, compliance gap identification, remediation planning and regulatory responses, helping organisations address weaknesses effectively and maintain constructive engagement with regulators.
GMP & Pharmaceutical Training
Rose Pharma Solutions delivers specialist GMP and pharmaceutical training, including in-house training, coaching and public training courses tailored to the needs of pharmaceutical, biotechnology and advanced therapy organisations.
Our training is delivered by experienced former regulators and industry professionals, combining regulatory knowledge with practical experience across pharmaceutical quality, manufacturing and compliance.
Courses can cover areas including GMP, regulatory compliance, inspection readiness, quality systems, manufacturing and pharmaceutical compliance, with content tailored to your organisation and its specific requirements.
Our practical approach helps teams understand not only what regulations require, but how those requirements can be applied effectively within their roles and working environment.