At Jenson Pharmaceutical Services Ltd we pride ourselves on putting our customers first and wherever possible will work with you to meet your needs for pre-authorisation, post-authorisation or organisational support. Our Regulatory Team has experience of working within the Big Pharma and generic industries as well as at regulatory authorities and within the UK Health Service. We can provide you with the services of both a Qualified Person and a Qualified Person for Pharmacovigilance. As well as good regulatory and pharmacovigilance experience we also have experience of managing change in large and small organisations, and can assist you with reviews of your organisational structures and systems. A summary of the services we can offer is shown below but please see our A-Z of Regulatory Services for the full list of how we can help you.     Marketing Authorisation applications: We can work with you before submission in designing a regulatory strategy and programme that meets your needs and that of the European Union regulatory authorities. We can provide the following services to our Customers: Advice on dossier completion Preparation of applicant’s and restricted parts of Drug Master Files, including Quality Overviews Preparation and management of CEP applications (Certificates of Suitability) Advice on bioequivalence study design and monitoring of bioequivalence studies Preparation of Summary of Product Characteristics, Labelling and Patient Information Leaflets and assistance with setting up and running leaflet user tests Regulatory support during the assessment of abridged National, DCP and MRP applications in both hard copy and electronic format   Please see our A-Z of Regulatory Services for full details of the many services we can offer you. Post-authorisation regulatory and pharmacovigilance support: We can work with you once you have your Marketing Authorisation to ensure that your post-authorisation requirements and responsibilities are met. We can provide the following services to our customers:   Preparation of annual product reviews GMP audits of drug substance and drug product manufacturers Regulatory maintenance (variations and renewals) Pharmacovigilance services Batch release of product in the EU   Please see our A-Z of Regulatory Services for full details of the many services we can offer you. Organisational support We can work with you in helping to establish or review your organisational structures and quality systems, to ensure that these meet your requirements. We can provide the following services to our Customers:   Organisational structural review Standard Operating Procedure review and preparation Strategy review   Please see our A-Z of Regulatory Services for full details of the many services we can offer you.