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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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Essential Aspects of Labeling for Clinical Supplies and Investigational Products

Blogs, Clinical Regulatory, Regulatory /

With the expansion of clinical research and development, precise labeling of investigational products is not merely a formality but a critical aspect ensuring the safety, efficacy, and regulatory compliance of clinical trials. Pharmaceutical companies are obliged to follow an integrated approach in labeling considering all aspects of clinical study planning to promote multilingual and multicultural

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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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Web-based Lifecycle Management Tool

Case Studies, Regulatory /

Customer Requirement: A Non-profit organization faced challenges in tracking and monitoring the registration status of their products in respective regions. This is because they had one product  in multiple markets that were each in different stages of their lifecycle. Siloed and disconnected tracking systems meant that the organization was left with little insight into the

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