DDReg Pharma- Consulting in regulatory affairs and drug safety

  Cosmetic ProductsRegistration Process in Mexico As the Mexican cosmetics market continues to expand, attracting attention from global beauty brands, understanding local regulatory requirements becomes essential for successful market entry. Navigating the complexities of Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios ( COFEPRIS ), the country’s regulatory authority overseeing health and safety, is critical for ensuring that your products meet local standards and reach consumers without delay. For international brands, this often involves not only completing the COFEPRIS cosmetics registration process but also partnering with an Importer of Record (IOR) to manage compliance, importation, and ongoing regulatory obligations. In this blog, we’ll explore the key aspects of COFEPRIS cosmetics registration, the role of the IOR, and practical steps for brands looking to successfully bring their products into the Mexican market. COFEPRIS’ Role in Cosmetics Registrat...

  Customer Requirement A large US-based pharmaceutical company with a broad global footprint, multiple manufacturing sites, and an extensive pharmaceutical portfolio needed reliable  local pharmacovigilance  (PV) compliance support across 11 international markets covering over 30 marketed products. The brands under its portfolio had significant visibility and consumer demand, making any PV non-compliance a high regulatory and reputational risk. To ensure seamless operations, the company’s Global Patient Safety team sought a partner capable of deploying qualified local QPPVs across  11 countries of Middle East and APAC .   Problem Statement The client required swift and compliant setup of local PV infrastructure in regions with varying and evolving regulatory expectations. Key challenges included:   Absence of  local QPPVs  in several target countries   Imminent agency inspections demanding urgent compliance readiness   Need to align and ...

India’s rapidly expanding healthcare market presents immense opportunities, but also a complex regulatory environment. For businesses looking to introduce pharmaceutical products, medical devices, cosmetics, food supplements, nutraceuticals, or biologicals, understanding and complying with the stringent regulations set by authorities like the Central Drugs Standard Control Organisation (CDSCO) and the Food Safety and Standards Authority of India (FSSAI) is paramount. This guide provides an overview of key   regulatory affairs services   essential for successful market entry and sustained compliance in India. The Central Drugs Standard Control Organisation (CDSCO): The Apex Regulator The CDSCO is India’s primary national regulatory authority, responsible for ensuring the safety, efficacy, and quality of drugs, medical devices, and other healthcare products. Its stringent requirements, though aimed at public safety, can be challenging for manufacturers seeking marketing authoriz...

  Safety Reporting in the EU With safety reporting in the European Union (EU) entering a new era of digital integration and oversight, pharmacovigilance systems have become more connected, data-driven, and strategically central to  regulatory compliance . What once revolved around manual case handling and isolated national databases has transformed into a highly interconnected pharmacovigilance network. This shift is not only redefining how  Marketing Authorisation Holders  (MAHs) manage  Individual Case Safety Reports  (ICSRs), but it’s also reshaping their overall safety strategy. The regulatory landscape has gone far beyond the central  EudraVigilance  system. Tools like EVDAS (EudraVigilance Data Analysis System) and SPOR (Substance, Product, Organisation, and Referential data services) have become central to pharmacovigilance compliance. However, with increased automation, transparency, and interconnectivity come greater complexity and respon...

  When a US-based biopharma company faced an FDA clinical hold due to preclinical toxicology concerns, DDReg stepped in. Our regulatory and toxicology experts conducted a deep-dive review of IND data, identified dose-justification gaps, and developed a scientific response package that led to conditional lifting of the hold. Result?  The sponsor resumed its Phase 2 trial without derailing development timelines or investor confidence. This case study highlights how expert toxicological insight and regulatory strategy can turn a major obstacle into continued progress. 🔍  Explore the full case study:   https://resource.ddregpharma.com/case-studies/fda-clinical-hold-lifted-with-ddregs-toxicology-expertise/ #RegulatoryAffairs #ClinicalTrials #FDA #DrugDevelopment #Toxicology #Pharma #DDReg #RegulatoryStrategy

  In the global life sciences industry, whether you’re launching a new pharmaceutical, a  medical device , or a personal care product, the responsibility doesn’t end at regulatory approval. It extends across the product lifecycle, driven by a commitment to patient and consumer safety, and reinforced by an evolving web of global regulatory requirements. Traditionally associated with large pharmaceutical corporations, vigilance is now a critical function for biotechs, MedTech innovators, cosmetic brands, and emerging-market players alike. But here’s the challenge: vigilance isn’t one-size-fits-all. Different product categories demand different vigilance systems, each with its own definitions, rules, timelines, and reporting structures. Let’s explore the three foundational types of vigilance that every regulatory, safety, and quality professional must understand and master. What is Vigilance in Life Sciences? At its core, vigilance is the continuous process of monitoring, detecti...