Regulatory Affairs

Our comprehensive Regulatory Services are designed to guide you through the complexities of global pharmaceutical compliance. From dossier compilation and submission management to strategic regulatory planning, we ensure your products adhere to the highest regulatory standards worldwide. Our capabilities include:

• Product registration & dossier preparation (CTD / eCTD / ACTD)
• Country-specific regulatory documentation support
• Export registration & market authorization assistance
• GMP, WHO-GMP, COPP & Free Sale Certificate coordination
• Labeling, packaging & artwork compliance as per local regulations
• Pharmacovigilance & post-marketing regulatory support
• Regulatory gap analysis and compliance consulting
• Coordination with regulatory authorities & partners

Pharmacovigilance Support/Clinical Services

We provide end-to-end Pharmacovigilance solutions to ensure patient safety and full regulatory compliance.

1. Safety, Efficacy & Literature Reporting
2. BA/BE Studies
3. BTIF/Biowaiver Form
4. SmPC/PIL/Insert Writing
5. PSUR/RMP
6. Clinical Trials

GMP Audit & Trainings

• We provide comprehensive Good Manufacturing Practice (GMP) audits to ensure full compliance with international regulatory standards.
• Our GMP audits identify gaps, mitigate risks, and strengthen quality management systems across your operations.
• We offer customized GMP training programs designed to meet industry-specific regulatory requirements.
• Our training sessions empower teams with practical knowledge of quality systems, documentation, validation, and data integrity.

eCTD Publishing & Submission Services

• We provide end-to-end eCTD publishing and submission services to support efficient global regulatory filings.
• Our team ensures accurate compilation, validation, and timely submission of electronic regulatory dossiers.
• We deliver compliant, high-quality eCTD submissions aligned with regional health authority requirements.
• Our publishing experts streamline complex documentation into fully validated electronic submissions.

Gap Analysis/Queries

• We provide comprehensive gap analysis services to identify deficiencies, risks, and compliance gaps in regulatory documentation.
• Our structured assessments ensure alignment with current regulatory requirements and agency expectations.
• We proactively identify potential submission weaknesses before regulatory review.
• Our team delivers actionable recommendations to strengthen your regulatory strategy and documentation.