Core services

OUR SERVICES

Expert guidance to ensure pharmaceutical products comply with global regulatory requirements, streamlining approvals and market entry.

Comprehensive PV solutions including adverse event monitoring, risk management, and regulatory reporting to ensure patient safety and compliance.

High-quality preparation of clinical and regulatory documents like clinical trial reports, summaries, and dossiers for successful submissions.

End-to-end consulting for life sciences and MedTech companies to meet regulatory standards and achieve smooth product approvals.

Specialized regulatory strategy, submissions, and compliance support for medical device manufacturers across global markets.

Preparation and formatting of regulatory submissions (e.g., eCTD) for medical devices to meet specific authority requirements.

Development of compliant labeling, IFUs (Instructions for Use), and technical documents to meet global standards.

In-depth assessment of regulatory gaps with actionable strategies to achieve compliance and correct deficiencies.

Assistance with preparing, filing, and managing medical device submissions for faster approvals in multiple jurisdictions.

Direct coordination with Ministries of Health and regulatory authorities to facilitate smooth communication and approvals.

Detailed analysis of existing processes or documents to identify gaps and provide tailored consulting for compliance improvement.