In the pharmaceutical industry, drug safety and compliance are the backbone of patient trust and global acceptance. With increasing international scrutiny, effective pharmacovigilance and regulatory support are essential for every pharmaceutical company. At Vaccure Pharma, we provide structured post-marketing surveillance and full regulatory guidance to ensure safe, timely, and compliant delivery of pharmaceutical products across the globe.

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✅ Why Pharmacovigilance Matters – Pharmacovigilance and Regulatory Support

Pharmacovigilance (PV) refers to the collection, monitoring, and analysis of data related to drug side effects. It ensures that patients continue to benefit from the medicine while minimizing any potential risks. Vaccure Pharma’s robust PV program includes:

  • Continuous adverse drug reaction (ADR) tracking
  • Spontaneous and structured reporting systems
  • Benefit-risk evaluation models
  • Case documentation for regulatory filings

This proactive approach ensures public safety while meeting the requirements of agencies like CDSCO, USFDA, EMA, and WHO.

📋 Comprehensive Regulatory Support Services

Navigating regulations across various regions can be challenging. Our regulatory affairs team simplifies this process by offering:

  • Compilation of dossiers in CTD and ACTD formats
  • Preparation of COA, COPP, FSC, and Stability Reports
  • Market-specific labeling & artwork compliance
  • Registration and renewal support with local MOH
  • Post-approval variation submissions and renewals

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🌍 Supporting Global Pharmaceutical Compliance

Vaccure Pharma works with global partners to ensure safe and legal drug availability across:

  • Africa – Ghana, Ethiopia, Nigeria
  • Asia – Philippines, Vietnam, Cambodia
  • Middle East – Iraq, Saudi Arabia, UAE
  • Oceania – Australia, New Zealand (TGA documentation provided)
  • Europe & CIS – Ukraine, Georgia, Armenia

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🧪 Integration with Manufacturing & Export

We don’t just stop at regulatory submissions. Our integrated system includes:

  • WHO-GMP certified manufacturing
  • ISO 9001:2015 compliant practices
  • Temperature-controlled logistics
  • Pharma B2B and white-label solutions
  • Regulatory document translation and legalization

Whether it’s a new drug application or a variation update, our regulatory team works in sync with R&D, QA/QC, and export departments.

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🚀 Trust Vaccure Pharma for Pharmacovigilance & Regulatory Excellence

With a strong foundation in global compliance and drug safety, Vaccure Pharma ensures your product meets the highest regulatory standards—anywhere in the world. Whether you’re launching in regulated markets or expanding distribution, we help you stay safe, efficient, and fully compliant.

📧 Email: info@vaccurepharma.com
📞 Phone: +91 9925178885 / +91 2613101203
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