Regulatory Affairs Services

Global strategy. Local compliance. Submission-ready execution.

End-to-end regulatory support across EMA, UK MHRA, and US FDA for small-molecule pharmaceuticals.

Overview

Pharmegic offers end-to-end regulatory affairs support across the EMA, UK MHRA, and US FDA landscapes. We specialize in small-molecule pharmaceuticals, helping companies navigate complex filings, regulatory strategy, and lifecycle management with clarity and precision.

Whether you’re launching a new product, seeking scientific advice, or preparing for variations and renewals, our team operates as an extension of yours — regulatory-aligned, submission-ready, and commercially focused.

EMA Regulatory Services

Supporting centralized, decentralized, and national procedures across Europe.
  • Regulatory strategy and procedure selection (CP, DCP, MRP, NP)
  • Scientific advice briefing book preparation and support
  • eCTD dossier preparation (Modules 1–5)
  • Quality, nonclinical, and clinical module authoring and review
  • Response handling for List of Questions (LoQs) and Day 120 comments
  • Lifecycle management (variations, renewals, Type IA/B, notifications)

Centralised · Decentralised · National

UK MHRA Regulatory Services

Post-Brexit regulatory clarity for UK-specific filings.
  • National procedure strategy and guidance
  • eCTD dossier compilation and electronic submission
  • Pre-submission meetings with MHRA
  • Accelerated review, rolling review, and innovation pathways
  • Management of ongoing lifecycle activities (variations, PSURs, renewals)

Post-Brexit Clarity

US FDA Regulatory Services

Regulatory pathways tailored for speed and compliance.
  • Regulatory pathway assessment (505(b)(1), 505(b)(2), ANDA)
  • Pre-IND and pre-NDA meeting support
  • IND/DMF/ANDA/NDA dossier preparation (US Module 1 formatting)
  • SPL creation, ESG submission, and eCTD publishing
  • Written responses to IR, DRL, CRL
  • Labeling and SPL compliance

Speed · Compliance · Clarity

Why Pharmegic

The partner who delivers science-first, lean, and globally aligned solutions.

Regulatory expertise across EU, UK, and US

Deep knowledge of EMA, MHRA, and FDA frameworks — one partner, three markets.

Scientific and commercially aligned documentation

Every dossier is built for both regulatory approval and commercial success.

Deep experience with injectables, orals, and sterile products

Specialized regulatory knowledge across complex dosage forms.

CRO/CDMO integration for end-to-end development + submission support

Seamless handoff from R&D to regulatory — no gaps, no delays.

Your R&D Journey, Visualized

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Regulatory Strategy

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eCTD Dossier Preparation

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Submission-Ready Compliance

Need a regulatory partner who speaks the language of both science and compliance?

Let’s connect. Whether you need EMA, MHRA, or FDA support, we’re ready to navigate your filing.
Contact our Team