From Strategy to Maintenance in the Regulatory Field
Divided into clear modules that cover the complete product life cycle.
Regulatory Classification Assessment: Determine if the product is a drug, device, supplement, etc., and its risk class according to each target country.
Regulatory Roadmap: Key deliverable. A detailed roadmap with the steps, timelines, estimated costs, and specific requirements for each market (US, EU, Latin America, etc.).
Gap Analysis: Audit the client's existing dossier or documentation against the target authority's requirements, identifying gaps and opportunities for improvement.
Test Strategy (Preclinical/Clinical): Advise on the studies necessary to meet regulatory requirements.
Regulatory Consulting and Strategy, the client's strategic arm
Post-Presentation Support and Monitoring
Inquiry and Official Communication Management (Request for Information): Provide robust and technical responses to all inquiries from regulatory authorities, leading the communication strategy.
Regulatory Intelligence: Subscription service or reports that alert clients to imminent regulatory changes affecting their products.
Change and Renewal Management: Proactively manage changes to registrations and license renewals, preventing expiration.
Pharmacovigilance/Device Surveillance Support: Implement systems or provide support in managing adverse event reports.
Development of Complete Dossiers:
Medicines: CTD (Common Technical Document), eCTD, MAA (Marketing Authorization Application).
Medical Devices: Technical File, STED (Summary Technical Documentation), Documentation for EU MDR/IVDR.
Supplements: Safety and efficacy dossiers, files for health claims.
Translation and Localization Services: Technical and certified translations of product labels, instructions for use, and documentation.
Registration and Licensing Management: Filing and tracking of applications with health authorities (FDA, COFEPRIS, EMA, among others).
Preparation and Management of Files
Centralized Executive Dashboard:
View all projects with real-time status updates (e.g., "In Development," "Submitted," "Under Review," "Approved").
Key Performance Indicators (KPIs): Average approval times, success rate, and upcoming project deadlines.
Secure and Organized Document Repository:
Centralized and encrypted storage for all files, certificates, correspondence, and approvals.
Version control and change history. "You always know the latest approved version."
Task and Milestone Management Module (Project Management):
Each project (e.g., "Product X Registration in Mexico") is divided into assigned tasks with due dates and internal and client responsible parties.
The client can view progress as a percentage and upcoming milestones.
Systems integration
Intelligent Alerts and Expiration System:
Automatic and proactive alerts for registration renewals, maintenance payments, and required updates. This feature prevents problems caused by oversights.
Integrated Communication Module:
Internal messaging linked to each project, preventing information from getting lost in endless email chains.
Audited record of all interactions with health authorities (official correspondence, questions, answers).
Customizable Report Generator:
The ability for clients to generate status reports by product, country, or period, ideal for their internal compliance meetings.
