case studies

Case Studies

Clinical label regulatory reviews for more than 100 countries per their guidelines

A multinational labeling company was facing issues with their labeling information to be regulatory compliant with the ever-changing regulations and local requirements. They required to get the clinical labels reviewed within a short timeline per designated countries' current regulatory guidelines and prepare reports with discrepancies and remediation solutions.

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Updating of Non clinical and clinical module 4 and 5 with corresponding Non-clinical summary and overview

A top Europe based Pharmaceutical company was looking to update their existing non clinical and clinical modules with current data for new market registration of the products. IREG consulting completed this project to the client’s satisfaction in terms of quality and timelines.

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Regulatory strategy report for proposed new drug registration with drug regulatory authority - Central Drugs Standards Control Organisation (CDSCO), India.

iReg Consulting completed this project for a top multinational company. The concerned product was a New Chemical Entity (NCE) approved in Europe and to be launched in India. iReg Consulting drafted a complete regulatory strategy to launch NCE in India along with risk analysis and competitive marketing scenario.

Manufacturing sites consolidation project

A top multinational pharmaceutical company was facing issues due to a large number of third party manufacturing sites. They wanted to consolidate third party manufacturing chain to the designated manufacturing plants. This project enlisted a huge products’ list and more than 100 countries involved.

Read through this case to know more about how the project executed right from supplier communication, document management, in-depth gap analysis to Regulatory risk management reports, contact us for further details.

Compliance and remediation for pharmaceutical products with a repeated transfer history

iReg Consulting completed this project for a top Europe based pharmaceutical company. The project involved many old products with different strengths and repeated transfer history. It aimed to update the dossiers with the recent changes. CMC compliance review and the remediation for the discrepancies. iReg consulting completed this project with the finest of quality and within timelines.

Check out the case to see how iReg Consulting overcame all the challenges and completed the entire project, contact us for further details.

Variations applications to European regulatory authority for the sterile dosage form

iReg consulting offered advice on this project to one of our Indian client companies. Variations applications to be filed for active and finished product sections for this particular sterile dosage form to one of the European regulatory authorities.

Read the case to know it all and how iReg consulting rectified some negative remarks of the regulatory authority , contact us for further details.