Regulatory Consulting

Drug regulations are complex, ever-evolving, and demand precision. Whether you’re preparing a new drug application or facing post-approval compliance issues, having the right regulatory guidance can mean the difference between fast approval and costly delays.

At DrugRegulatoryAffairs.in, our Regulatory Consulting Services are designed to help pharma companies, startups, and CROs develop smart, compliant, and risk-free regulatory strategies in line with Indian and global standards.

🔍 What We Do

We provide end-to-end regulatory advice tailored to your product type, market strategy, and target region (India, USFDA, EMA, ASEAN). Whether it’s a new chemical entity (NCE), generic drug, biologic, or vaccine, our experts guide you from the development phase through licensing and beyond.

🧾 Consulting Areas

📌 Pre-Submission Regulatory Strategy

  • Selecting the correct application pathway (New Drug, FDC, Generic, Biologic)
  • Identifying required approvals from CDSCO, DCGI, or state licensing authorities
  • Gap analysis and roadmap for regulatory filings

📑 Submission Preparation & Review

  • Technical review of dossiers before submission (CTD/ACTD/eCTD)
  • Identification and resolution of non-compliance risks
  • Guidance on labeling, packaging, and artwork compliance

✉️ Regulatory Query Handling

  • Response drafting for CDSCO deficiency letters or queries
  • Scientific and regulatory justification support
  • Communications with licensing authorities

🌍 Global Regulatory Pathways

  • Comparative guidance on CDSCO vs. USFDA vs. EMA submissions
  • Export documentation and WHO certification advice
  • ASEAN, GCC, and African country-specific advice (for Indian manufacturers)

👤 Who Should Use This?

  • Pharmaceutical companies launching new products or expanding to global markets
  • Regulatory affairs teams needing expert review or support
  • Startups in biotech, phytopharma, or nutraceuticals entering regulated environments
  • CROs looking for strategic oversight for clinical trial applications

📈 Why Choose Us?

  • Multi-domain regulatory expertise (CDSCO, FDA, EMA, WHO, ICH)
  • Proven success in minimizing rejections and speeding up approvals
  • Personalized consulting, not templated advice
  • Continuity of support throughout the drug lifecycle