Our
Process
End-to-end regulatory support for international pharma expansion.
Strategic Portfolio Screening
Meditra Healthcare begins with a comprehensive review of the manufacturer’s product portfolio, identifying formulations with strong commercial viability in regulated markets. This includes evaluating the therapeutic relevance, dossier status, and production capabilities.
Market analysis follows, comparing the client’s offerings against demand dynamics, pricing benchmarks, and existing competitors in the EU. Based on this intelligence, Meditra delivers tailored strategic recommendations on which molecules to prioritize and how to position them effectively within the market landscape.
Dossier Assembly & CTD Optimization
Preparing a complete CTD (Common Technical Document) dossier is a critical foundation. Meditra Healthcare coordinates the collection and structuring of modules 1 through 5—covering administrative, quality, non-clinical, clinical, and summary data—ensuring full alignment with EMA or national authority requirements.
Technical experts and regulatory consultants work closely with the manufacturer to bridge documentation gaps, harmonize data with ICH guidelines, and deliver a fully validated, submission-ready file. Optimization includes addressing formatting inconsistencies and reducing reviewer queries.
GMP Alignment & Inspection Readiness
Compliance with EU GMP standards is non-negotiable for market access. Meditra Healthcare guides manufacturers through the regulatory and operational steps required to secure EU-recognized GMP certification, including QMS enhancement and validation planning.
Support also includes simulation audits, preparation of CAPA responses, and assistance during official inspections. This ensures sites are technically, procedurally, and culturally ready for scrutiny by EU authorities or Qualified Persons.
Quality Oversight & Batch Release
Meditra Healthcare oversees batch certification to ensure that each lot complies with stringent EU release standards. This involves coordinating product sampling, third-party lab testing, and alignment with pharmacopoeial specifications for sterility, stability, and assay.
Batch release is authorized in collaboration with a registered Qualified Person (QP), who signs off on the final product for distribution. This process is managed through an integrated QA system that includes traceability, deviation handling, and lifecycle tracking.
Regulatory Pathway Strategy
Every molecule and market combination requires a customized submission route. Meditra Healthcare evaluates whether the Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), or Centralized Procedure (CAP) best aligns with the product’s scope, data maturity, and geographic targets.
This decision is based on a matrix of factors including indication class, reference market availability, agency preferences, and submission timelines. The result is a regulatory map that maximizes approval speed and commercial exposure.
RMS & CMS Coordination
For DCP or MRP filings, seamless communication with the Reference Member State (RMS) and Concerned Member States (CMS) is crucial. Meditra Healthcare leads the negotiation process, ensuring harmonized evaluation, fast resolution of reviewer comments, and coordinated clock-stops.
The team maintains continuous engagement with assessors and translators, managing updates across all procedural milestones. This ensures regulatory continuity and reduces risk of dossier rejection or extension.
Submission & Lifecycle Control
Once the final strategy is in place, Meditra Healthcare handles the full digital submission, coordinating with EMA or relevant national portals. All content is compiled in eCTD format, cross-validated, and uploaded through secure channels.
Post-submission, Meditra tracks progress in real time, managing all agency feedback, version control, and documentation updates. This includes amendments, module replacements, and metadata consistency checks across platforms.
Regulatory Response Management
Agency queries can significantly delay approval if not addressed efficiently. Meditra Healthcare mobilizes its subject matter experts to draft scientifically sound and regulator-appropriate responses, integrating clarifications and supplementary data where needed.
Proactive engagement with authorities ensures rapid resolution. The team anticipates questions by pre-screening dossiers and preparing backup justifications in advance, reducing cycle times and building reviewer confidence.
Authorization & Post-Approval Services
After marketing authorization is granted, Meditra Healthcare remains involved to ensure sustained compliance and product availability. Services include pharmacovigilance setup, renewals, line extensions, and variation filings.
The company monitors local requirements, manages safety data submissions, and oversees packaging/labelling changes. This end-to-end approach helps clients maintain market access, avoid recalls, and prepare for audits or new launches.
