Stenova

Pharma Regulatory Consulting

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Years of Experience

We specialize in Regulatory Filing and Dossier Submission for pharmaceutical products across global markets.

stenova

about us

Committed to delivering reliable and compliant regulatory solutions.

As an independent regulatory consulting organization. We work in your best interest to ensure your dossiers, submissions, and documentation meet global regulatory standards with accuracy and compliance — every time.

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Our Mission.

We are committed to delivering precision-driven regulatory solutions that reduce approval delays, strengthen compliance, and support your long-term market growth.

Services

Regulatory Documentation & Submission Support Services

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Dossier Preparation (CTD)

We prepare structured, compliant dossiers in CTD formats tailored to regulatory requirements across regulated and semi-regulated markets. Ensuring accuracy, completeness, and alignment with regional guidelines.

Regulatory Filing & Submission

Comprehensive support for regulatory submissions globally, including initial application, variation filings, renewals, and lifecycle management. Ensuring smooth approval pathways with minimized regulatory obstacles.

Query Response

Professional handling of regulatory authority queries, clarifications, and technical justifications, GAP analysis, Various technical requirement supported by ongoing monitoring of global regulatory updates to ensure continuous compliance.

Consulting

The Future of Regulatory Compliance & Market Authorization Support

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Our expertise

We helps to accelerates market approvals.

Regulatory consulting is a specialized support service that ensures your pharmaceutical documentation, submissions, and compliance processes align with global regulatory authority expectations.

Dossier Compilation & Formatting

Preparation and structuring of regulatory dossiers

Market Authorization Support

Assistance with submission planning, variation filings etc.

Query Response & Support

Managing responses to regulatory authority questions

Compliance Monitoring

Continuous tracking of guideline and proactive upgrade

We strive to lead with precision, compliance, and global regulatory expertise.

Know All Capabilities

we are stenova medex

Passionate About Helping You Achieve Regulatory Success

We support pharmaceutical organizations in navigating complex global regulatory pathways. Our team delivers accurate documentation, structured dossiers, compliant submissions, and well-reasoned responses to authority queries — ensuring confidence and clarity throughout the approval process.

Regulatory insights that streamline approval timelines.
End-to-end support from dossier compilation to submission

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SERVICE PACKAGES

Choose the Right Regulatory Package

We offer flexible and scalable regulatory consulting packages to support your product documentation, submission, and compliance needs across global markets.