Shivahi Exim has a highly skilled in-house Regulatory team of experienced pharmacists that delivers timely and high-quality dossier submissions in accordance with CTD, eCTD, ACTD, and ICH requirements.
Our objective is to facilitate smooth, accurate, and efficient submissions to the respective Ministry of Health with country-specific documents and dossiers within committed timelines. With strong industry knowledge and hands-on regulatory experience, our experts effectively manage queries from both regulatory agencies and customers.
Preparation of high-quality dossier submissions in CTD, eCTD, ACTD, and ICH formats for global regulatory submissions.
End-to-end support for product registration with country-specific requirements and committed submission timelines.
Preparation and review of technical documentation to meet the standards of respective regulatory authorities worldwide.
Comprehensive labelling review to ensure compliance with market-specific regulations and MOH requirements.
Systematic compilation and quality review of all regulatory documents prior to submission to ensure accuracy and completeness.
Tailored regulatory strategies and submissions aligned to the specific requirements of each target market.