Life-Cycle Management

Regulatory strategy and maintenance support throughout product life-cycle post-approval:

• Complete portfolio maintenance for EU and US: management of variations, amendments, renewals, supplements, modifications, requests for information, and notifications, among others
• Dossier updates (CTD updates) and maintenance. Strategic writing and review for the preparation of complete dossier updates for new registration procedures, including expert’s signature. Update of dossier modules to respond to further generated clinical evidence
• CMC maintenance activities (aligned with compliance requirements) and Expert Reports
• Annual Safety Reports and other regulatory requirements
• Full cycle submission management and support

Expert support on responses to Deficiency Letters.

Dossier consolidation of legacy dossiers (Mod. 2.3 and 3) for eCTD publishing.

Ad hoc regulatory strategy.

Pharmacovigilance strategy and operations that responds to legal requirements and best enhances the safety profile of your product in real world application:

• QPPV (Qualified Person Responsible for Pharmacovigilance) appointment and follow-up, nationally and in EU and US
• Writing of Periodic Safety Reports (PSUR)
• Literature monitoring
• Pharmacoepidemiology
• ICSR (Individual Safety Case Report) management, including collection, evaluation, processing, distribution and reporting of cases.
• Preparation of PSMF (Pharmacovigilance System Master File), RMP (Risk Management Plans), PSURs (periodic Safety Update Reports), and handling of Case Management.
• Implementation of Adverse Event reporting tool.
• Social media deep screening to monitor drug safety information within digital environment:
  • Active listening of brand/product
  • Multiple digital platforms with more than 2 billion URLs
  • 24/7/365 monitoring solution
  • Segment by language and/or country
• Analysis and validation of contents:
  • Expert drug safety team
  • In accordance with legislation and/or client requirements
  • Immediate communication of detected adverse drug reactions

Management and follow-up of data and evidence generation post-approval.

• Data generation and consolidation for evidence demonstration: data collection or extraction, verification, mapping and cleaning
• Safety data exchange agreements
• Data entry and submission for xEVMPD, IDMP, SPL and other formats, as needed
• Publishing and submission for human medicines in eCTD format for EU and US
  • Comprehensive eCTD services
  • eCTD compilation and publishing
  • Full life-cycle support for Europe, USA, Canada, Switzerland, Saudi Arabia, GCC, and more
  • Information management (RIMS solution)
  • Software installation, training, validation and support
• Adequation and data retrieval and management to ISO IDMP standards
• Tool review and selection (RFP, RFI)
• Tool and process adaptation and implementation
• Data mapping with SPOR master data
• Gap analysis of IDMP readiness

Ensuring complete and constant subjection to compliance based on specific regional regulations:

• Inspection and Audit system and compliance.
• Audit PV systems and support for Quality System set-up
• CMC compliance and regulatory gap analysis
• Review of promotional or training materials and of commercial activities post-authorization.
• Management of labelling.

Readability tests for further EU registration processes.

Data retrieval for price and reimbursement strategies.

Price and reimbursement for new medicinal products and for generic products in Spain.

Marketing Authorization transfer management.

Support in UK with new MHRA requirements:

• Acting as UK-QPPV
• Reporting adverse events and submissions of PSURs to MHRA
• Batch update all your records with the new QPPV and PSMF information in the Article 57 database
• Holding your Pharmacovigilance system master file at our location
• Submission in UK using the new National Portal
• National procedures in UK, accelerated and Rolling reviews, national variations
• Amended packaging and leaflet
• Baselines for grandfathered centralized products
• Assessment of Brexit Regulatory impact and development of Brexit transition strategy
• Management of MAH transfers and other necessary variations

Medical device related post-commercialization regulation:

• Medical device post-market surveillance Plans and Reports
• Technical File core-parts revision/compilation/maintenance for medical devices
• Quality management System (QMS) design and implementation, based on ISO 13485 and 21CFR 820 Quality Management Systems
• Manufacturer and supplies audits
• QMS self-inspections
• Notified Body /FDA – mock inspections

Validation and qualification of medical devices manufacturing process, equipment and facilities.

SaMD validation for medical devices: Standalone software as medical device (SaMD). Computerized Systems as part of a medical device.