Regulatory & Pharmacovigilance Services

These services would be provided via our group company Callisto Regulatory Consulting Ltd who can support you with Human, Veterinary and Herbal medicines regulatory advice and Pharmacovigilance services.

Regulatory Services include:

• Preparation of regulatory dossiers for the UK, Europe and other markets
• Management of national, EU mutual recognition and decentralised licensing
• Preparation and signature of Quality Overall Summaries, Nonclinical and Clinical Overviews
• Preparation of Risk Management Plans and Environmental Risk Assessments
• Preparation of applications in vNeeS and eCTD format and ‘Due diligence of dossiers'
• Life cycle management including all types of variations, renewals and Change of Ownership applications
• Preparation of SmPCs, labelling and leaflets and PIQU submissions
• Reclassification applications
• Applications for Certificates of Suitability via EDQM
• Liaison with Regulatory Authorities including attendance at Scientific Advice Meetings
• Sunset Clause applications

PV services include:

• Setting up quality systems to fulfil Marketing Authorisation Holders Pharmacovigilance obligations
• Weekly literature searching to identify potential adverse events related to Marketing Authorisation Holders products
• Collation, assessment, follow-up and reporting of spontaneous adverse reactions received by the Marketing Authorisation Holder
• Electronic reporting via EVWeb
• Review of PVORs
• Preparation of Periodic Safety Update Reports
• Signal detection Safety Reports
• Maintenance of product information including SmPC, leaflet and labelling
• Appropriate Qualified Person and Deputy Qualified Person for Pharmacovigilance including 24-hour cover
• Provision of Medically Qualified Person & medical information services
• Production of Risk Management Plans and implementation of Risk Minimisation Measures
• Auditing existing Pharmacovigilance systems & provision of training
• Preparation for and assistance during Pharmacovigilance inspections

Please visit our Partner company “Callisto Regulatory Consulting Ltd”.