Pharmaceutical Regulatory Services

Strategic regulatory affairs for drug development and global market authorization

Navigate Complex Pharmaceutical Regulations

From molecule to market - comprehensive regulatory support

Regulatory Affairs

  • Global Regulatory Strategy
  • Dossier Gap Analysis & Remediation
  • CMC Writing & Documentation Review
  • ICH Guidelines Compliance
  • CTD/ACTD Dossier Preparation
  • Computer System Validation (CSV)
  • FDA 483 Resolution
  • Drug Master File (DMF) Preparation
  • ANDA/NDA/IND Submissions
  • Clinical Trial Applications (CTA)
  • Variation Applications (Type IA, IB, II)
  • Marketing Authorization Applications

Quality Assurance & QMS

  • GMP & GDP Design Quality
  • Equipment Qualification (IQ/OQ/PQ)
  • Process Validation
  • New Regulations Implementation
  • External Audit Preparation
  • CAPA Procedure Management
  • Investigation & Root Cause Analysis
  • ICH Q9: Quality Risk Management
  • WHO, FDA, MHRA, TGA Compliance
  • Gap Assessment & Remediation
  • Cleaning Validation
  • Analytical Method Validation
  • Stability Studies Design

Regulatory Coverage

Expertise across major global markets

🇺🇸

US FDA

IND, NDA, ANDA, DMF submissions

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EMA (European Union)

MAA, Variations, CTD dossiers

🇮🇳

CDSCO (India)

Drug Registration, Import Licenses

🌍

WHO

Prequalification Program

🇦🇺

TGA (Australia)

Australian Registration

🇨🇦

Health Canada

Drug Submissions

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SAHPRA (South Africa)

Registration Services

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MHRA (UK)

UK Registration

Drug Types We Support

Comprehensive expertise across all pharmaceutical categories

Small Molecules

Biologics

Biosimilars

Generic Drugs

Over-the-Counter (OTC)

Prescription Drugs

Combination Products

Herbal/Ayurvedic (India)

Clinical Development Support

  • Protocol Development
  • IND/CTA Preparation
  • Investigator's Brochure
  • Clinical Trial Monitoring
  • Clinical Study Reports
  • Bioequivalence Studies
  • Safety Reporting
  • Ethics Committee Submissions

Pharmacovigilance Services

  • Safety Database Management
  • Adverse Event Reporting
  • PSUR/PBRER Preparation
  • Risk Management Plans (RMP)
  • Signal Detection & Evaluation
  • Regulatory Safety Updates

Success Metrics

98%

Approval Success Rate

25%

Avg. Timeline Reduction

0

Critical Audit Findings

Accelerate Your Drug Development Journey

Schedule a pharmaceutical regulatory consultation with our experts

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