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Case study on Pharmacovigilance Auditing Project

PV System Audit Uncovers Gaps, Boosts Readiness

Case Studies /

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 

Case Studies, Regulatory /

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

Case Studies, Regulatory /

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

Case Studies, Regulatory /

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

Case Studies, Regulatory /

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

Case Studies, Regulatory /

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

Case Studies /

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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Development of Pharmacovigilance Training Modules for US-based Educational Institute

Case Studies, Pharmacovigilance /

Customer Requirement: A USA-based educational institute specializing in providing training courses to its subscribers was looking to develop a course on pharmacovigilance. This course would be the first of its kind for the educational institute and would aim to provide a robust foundational knowledge base of pharmacovigilance, including key activities, processes, and the regulations surrounding

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Drug-device registration in CIS countries

Case Studies, Regulatory /

Customer Requirement: A global Non-profit organization in the area of female health & wellness wanted to obtain drug device registration and market authorization for their contraceptive that included its administration device, in CIS region, including Azerbaijan, Kyrgyzstan and Tajikistan.  The contraceptive was classified as a drug-device combination product for which regulations are challenging to navigate

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Accelerating access to Women’s Health products

Case Studies, Regulatory /

Customer Requirement: Women’s health and fertility are vital aspects of their overall well-being, and yet they often remain shrouded in silence and misconception. Every woman has the right to access healthcare, irrespective of their socioeconomic background or geographical location, though many women face significant challenges and barriers that restricts their access to the medications they

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