Regulatory Affairs + Development

Regulatory Affairs

At Madhav Pharma, we offer a comprehensive range of services designed to support your regulatory affairs needs and facilitate successful navigation through the complex regulatory landscape.

Our Services Encompass

Submission Forecast and Planning

Preparation and compilation of Drug Product Dossiers
Drug Master File (DMF)/ Active Substance Master File (ASMF) submissions for regulated and ROW markets
Certificate of Suitability (CEP) applications
WHO Dossier preparation
CMC documents authoring for drug product dossiers of both small and complex molecules
Cosmetic dossier (PIF) drafting
Regulatory operations management
Preparation and submission of diverse regulatory submissions to health authorities in CTD and eCTD format
Regulatory submission lifecycle management

Consulting Services

Regulatory strategy development and consultation
Quality compliance and audit support
Regulatory intelligence gathering and analysis

Developmental Support

Characterization and analytical method development support
In-silico genotoxicity assessment report
Permitted daily exposure (PDE) reports for APIs and impurities
Drug substance development and compliance services
Regulatory support throughout the developmental stages of pharmaceutical products

Regulatory Affairs

Regulatory Affairs

Our Services Encompass

Submission Forecast and Planning

Consulting Services

Developmental Support

Our Case Studies

PDE Latest Dimethyl Fumarate Oral Report

In Silico Mutagenicity Evaluation for (5-tert-butyl)-2-(chloromethyl)-1,3-dimethyl benzene

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We're dedicated to helping you achieve regulatory approval for your submission in your upcoming project.

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Madhav Pharma

Canada

India