Rose Pharma Solutions includes a very recent EU Inspector and one of the only accredited former inspectors in biological and advanced therapy medicinal products worldwide. Rose Pharma Solutions are therefore in a unique position to offer interpretation and guidance on current regulations with the expertise of a former inspector in these and other areas.
Rose Pharma Solutions are aware that arranging Innovation office meetings at the MHRA is increasingly difficult if at all possible. As a regular contributor to these meetings on GMP aspects of facility and process design, Rose Pharma Solutions are available to support as required with your new and innovative product.
Rose Pharma Solutions are experts in testing your facilities in a safe environment through mock-inspections. As experienced former regulators, Rose Pharma Solutions can give your site as real a mock inspection as required to challenge your processes but also help with guidance on any gaps that may be identified.
With unique previous experiences and training, Rose Pharma Solutions are able to ensure the most value is achieved from your for cause or routine supplier audits.
Rose Pharma Solutions are able to offer assistance before, during and after regulatory inspections specific and tailored to your requirements. Having worked within the compliance management team and with the MHRA Inspection Action Group, they are able to advise on processes and acceptable responses.
Rose Pharma Solutions are experienced trainers and have delivered both in house training and public courses.
