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Training Support on Process Validation Methods case study

Technical Upskilling through Expert Training Support on Validation Methods

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Customer Requirement A leading India-based pharmaceutical manufacturer with global operations sought to strengthen its internal technical capabilities related to Analytical Method Validation (AMV) and Process Validation (PV). With increasing regulatory scrutiny from agencies such as the FDA, EMA, and ICH, the company aimed to ensure compliance with current global guidelines while fostering cross-functional understanding across […]

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case study on Resolution of FDA 483 Inspection gaps

Successful Resolution of FDA 483 Inspection Gaps by Expert Pharmacovigilance Support

All Category, Case Studies, Pharmacovigilance, Regulatory /

Customer Requirement An India-based pharmaceutical company engaged in research and development (R&D) and manufacturing, faced critical challenges after an US FDA inspection revealed significant gaps in its pharmacovigilance (PV) compliance. The company required comprehensive support to address issues related to Individual Case Safety Reports (ICSRs) and Periodic Adverse Drug Experience Reports (PADERs) to comply fully

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Quasi Drugs in Japan and South Korea

Quasi Drugs: Regulatory & Commercial Considerations for Japan and South Korea 

All Category, Blogs, Regulatory /

In the dynamic Asia-Pacific market, quasi drugs represent a unique regulatory category that bridges the gap between cosmetics and pharmaceuticals. Particularly in Japan and South Korea, quasi drugs have gained traction for their hybrid benefits offering therapeutic claims while maintaining a relatively simpler regulatory pathway compared to full-fledged drugs.    Understanding the regulatory and commercial

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Case study on Pharmacovigilance Auditing Project

PV System Audit Uncovers Gaps, Boosts Readiness

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Customer Requirement A multinational pharmaceutical corporation (MNC) engaged in the manufacturing of therapeutics, food supplements, nutrition products, and treatments for nervous and respiratory systems, approached DDReg to conduct a comprehensive audit of its pharmacovigilance (PV) system. The audit was focused on evaluating the PV system being maintained at the company’s headquarters. The client also sought

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Regulatory Query Support with Expert PK Reanalysis & Justification

Addressing Regulatory Query with Expert PK Reanalysis & Justification 

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Customer Requirement A pharmaceutical company specializing in generic drug development was in the process of seeking market approval for a generic product. During the regulatory review process, the benefit-risk department of the regulatory authority raised a query related to the statistical analysis of the submitted bioequivalence (BE) study data. The company required a comprehensive and

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Project Management

Project Management to Overcome Leadership & Timeline Delays

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Customer Requirement  A pharmaceutical company required timely delivery of high-quality project management services without delays. The key objectives of the project were:  Ensuring on-time and quality-driven execution of regulatory submissions  Maintaining consistent project direction despite leadership changes  Managing political and time pressures without compromising project timelines  Ensuring timely submission of required documents from external stakeholders 

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Biosimilar Submissions Across 19 Emerging and ROW Markets case study

Accelerating Biosimilar Submissions Across 19 Emerging and ROW Markets

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Customer Requirement: A biopharmaceutical company aimed to submit 19 biosimilar applications across various emerging and Rest of the World (ROW) markets within a short timeframe. The company required a regulatory strategy that addressed potential gaps, identified the most efficient submission pathways, and aligned with diverse regulatory expectations to ensure successful and timely approvals. Problem Statement

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Pharmacovigilance Systems in the MENA Region case study

Developing Pharmacovigilance Systems in the MENA Region

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Customer Requirement: A regional regulatory authority in the MENA region sought to address critical gaps in their pharmacovigilance (PV) systems to enhance drug safety monitoring for a portfolio of their products, across the region. The key objectives of the PV system were as follows: Establishing robust PV systems in underdeveloped regions Aligning PV standards with

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data requirements for ANADA filings case study

Fulfilling stability data requirements for ANADA filings

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Customer Requirement: An animal product company, based in Ireland, wanted to file an abbreviated new animal drug application (ANADA) with the United States Food and Drug administration (US FDA) for its non-steroidal anti-inflammatory drug (NSAID) product. The drug is used to relieve pain and inflammation that is associated with osteoarthritis & control post-operative pain in

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Customized aRMM for National PV Center in Saudi Arabia

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Customer Requirement: A pharmaceutical company specializing in generic products, based in Saudi Arabia, required a customized additional risk minimization measure (aRMM) for its generic version of Pomaliomide capsules. This was a requirement of the regulatory agency, the Saudi Food and Drug Authority, in order to maintain safety and regulatory compliance. Problem Statement: The National Pharmacovigilance

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