Simplifying Compliance. Accelerating Market Entry

At Vetex Pharma, we act as a regulatory intelligence bridge — helping our clients interpret, compile, and submit documentation across complex, multi-jurisdictional requirements. Our in-house and partner network supports dossier readiness, gap analysis, and submission strategy tailored for both developed and emerging markets.

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🧾 API Portfolio Snapshot

Vetex Pharma offers a therapeutically focused range of high-quality, regulatory-compliant APIs. Below is a sample snapshot of our key categories.

🌍 Regions We Support

Region Regulatory Bodies / Requirements
🇺🇸 US USFDA – DMF (Type II), ANDA documentation
🇪🇺 EU EMA / National Agencies – CEP, CTD Modules
🌎 LATAM ANVISA (Brazil), INVIMA (Colombia), DIGEMID (Peru)
🌍 Africa NAFDAC (Nigeria), PPB (Kenya), SAHPRA (South Africa)
🌙 Middle East SFDA (Saudi), MOH (UAE, Egypt, Jordan)
🌏 Asia-Pacific CDSCO (India), DOH (Philippines), BPOM (Indonesia)

📑 Regulatory Services We Provide

  • DMF Preparation & Review: Formatting & review for USFDA, EU CEP, and more.
  • CTD / eCTD Dossier Development: Full Modules 1–5, tender & branded formats.
  • Gap Analysis: Identify documentation gaps & expedite readiness.
  • Site Audit Coordination: GMP / WHO-GMP audits or technical inspections.
  • Post-Approval Variation: CMC, API changes, labeling updates, requalification.

✅ Submission-Ready Documentation Includes

  • 📄 Certificate of Analysis (COA)
  • 🧪 Method of Analysis (MOA)
  • 📋 Batch Manufacturing Record (BMR)
  • 🧾 Stability Data, GMP/DMF/CTD Ready
  • 🌐 COPP / FSC / CPP (if applicable)

📊 Why Clients Choose Vetex Regulatory Services

  • 🌐 Multilingual dossier prep (EN, FR, ES, AR)
  • ⏱️ Rapid response for licensing & tenders
  • 💼 Experience with generics & niche formulations
  • 🔐 Full confidentiality & secure data exchange