Due Diligence of Dossier Assistance
Optimize Your Path to Regulatory Success with Expert Due Diligence Services, from Comprehensive Dossier Reviews to Strategic Guidance
Optimize Your Path to Regulatory Success with Expert Due Diligence Services, from Comprehensive Dossier Reviews to Strategic Guidance
We serve complete due diligence services for pharmaceutical products, ensuring regulatory compliance, mitigating risks, and optimizing dossier approval chances. Our expertise helps your company navigate the complex regulatory landscape confidently, achieving your regulatory goals effectively, thereby enhancing your chances of successful dossier approval.
Pharmaceutical and biotechnology corporations are shifting their approach from R&D to commercialization, as the development of new medications becomes more costly and time-consuming. Purchasing and licensing products are becoming the preferred method to reduce R&D expenditure and expedite product time to market. Due diligence is the initial phase of acquisition, aiming to identify potential gridlock during commercial launch or registration with health authorities.
Zenovel offers technical due diligence assistance for pharmaceutical companies, distributors, and start-ups during the initial evaluation phase of licencing discussions. We also assist with acquisition life cycle maintenance, focusing on regulatory and CMC sections of products. Our services consider various variables, including final outcomes, to ensure successful acquisitions.
We assist you in effectively navigating the intricate regulatory landscape by our thorough industry knowledge and experience.
Our assistance in the acquisition phase and commercialization focus helps reduce R&D expenditure and expedite product time to market.
Our services guarantee strict adherence to regulatory standards, reducing risks and enhancing the likelihood of successful dossier approval.
The European Union’s Good Manufacturing Practice (GMP) standards, as outlined in the Annex to the Guide to Good Manufacturing Practice for Medicinal Products, ensure the quality and safety of medicinal products, including those used in clinical trials. The Qualified Person (QP) plays a crucial role in batch certification, particularly for
In the intricate process of developing new pharmaceuticals, guaranteeing product safety, effectiveness, and adherence to global regulations is essential. Batch release testing acts as a pivotal quality assurance measure, confirming that medications comply with rigorous criteria before distribution. When combined with International Council for Harmonisation (ICH) standards, this testing framework
In the world of life sciences, quality isn’t just a benchmark—it’s the backbone of success. Three key pillars—Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP)—form the core framework that supports everything from product development to regulatory approval. These standards aren’t just industry buzzwords; they’re the
In the pharmaceutical industry, quality is paramount—and at Zenovel, we are deeply committed to delivering excellence in Quality Assurance (QA). Our focus is on ensuring that every medicine is developed, manufactured, and delivered with safety and reliability as top priorities. QA is embedded in every stage of the pharmaceutical lifecycle—from
The U.S. Food and Drug Administration (FDA) emphasize the importance of data integrity in pharmaceutical manufacturing, particularly under its Current Good Manufacturing Practices (CGMP) rules. However, issues like fake lab results and sloppy record-keeping persist, posing risks to patients and losing confidence in the system. Independent oversight is crucial to
In the rapidly evolving pharmaceutical industry, assuring product quality and customer safety is a need. This endeavour continues to be based on validation, a methodical procedure to verify that manufacturing procedures and equipment consistently deliver high-quality outcomes. A strong strategy to validation is required in 2025 due to the complexity
