Regulatory Affairs Submission Management

Streamlined Coordination for Efficient Market Approvals

Overview

At North Pharma Consulting, we provide end-to-end management of regulatory submissions — from dossier authoring to agency communication — ensuring that your product moves smoothly from development to approval.
Our experienced regulatory team coordinates every step of the submission process to minimize risk, reduce delays, and ensure full compliance with international standards.

We manage submissions across EU, UK, CIS, MENA, LATAM, US, and ASEAN markets, adapting strategies to the specific procedural and technical requirements of each region.

Key Challenges We Address

  • Complex and evolving submission procedures across regions
  • Time-consuming coordination between global stakeholders
  • Incomplete or inconsistent documentation in CTD modules
  • High risk of queries and delays due to unclear agency communication
  • Limited internal resources for simultaneous submissions

Our Approach

1. Dossier Preparation & CTD Authoring

We assist in compiling, structuring, and validating your dossier in the Common Technical Document (CTD) format — Modules 1–5 — in compliance with regional standards.
Our team ensures consistency, completeness, and accuracy to strengthen your submission and minimize agency queries.

2. Submission Pathway Selection

Based on your product type and target market, we determine the most effective regulatory route — Centralised Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), or National Application — and prepare a clear roadmap to execution.

3. Application Submission & Monitoring

North Pharma Consulting manages the full submission process, including electronic gateway uploads (eCTD, NeeS), validation, tracking, and follow-up.
We proactively monitor progress and maintain transparent communication with authorities and local agents.

4. Deficiency & Query Management

Our regulatory specialists coordinate timely responses to agency questions, requests for clarification, or deficiency letters, ensuring that all feedback is addressed with precision and supported by compliant documentation.

5. Lifecycle Follow-Up & Post-Approval Activities

We continue to support you after approval by managing renewals, variations, and line extensions to maintain compliance throughout the product lifecycle.

Benefits

  • Accelerated approval timelines through strategic submission planning
  • Consistent communication with regulatory authorities
  • Reduced number of queries and deficiencies
  • Seamless coordination between global stakeholders
  • Continuous post-approval support and lifecycle compliance

Why Choose North Pharma Consulting

With over 15 years of experience managing regulatory submissions across global markets, North Pharma Consulting is your trusted partner for reliable and efficient submission execution.
Our integrated team ensures that your documentation is accurate, compliant, and delivered on time — so your product reaches patients faster.