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Navigating the Complexities of Drug Development | A Step-by-Step Guide

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  The pharmaceutical industry is evolving rapidly, with drug development at its core. However, the journey from initial concept to market approval is fraught with challenges. In this blog post, we'll explore the key steps in the drug development process and how Purology's expertise can guide companies through each phase efficiently and compliantly. Understanding the Preclinical Phase The preclinical phase lays the groundwork for all future development efforts. During this stage, extensive laboratory research is conducted to identify promising drug candidates. Preclinical studies focus on understanding the drug's safety profile and efficacy through in vitro (test tube) and in vivo (animal) experiments. Key Considerations Safety and Toxicology Testing: Before advancing to human trials, it's critical to ensure that the drug is safe and non-toxic. Approximately 30% of drug candidates fail during this stage due to safety concerns. Regulatory Submissions: Companies must sub...
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The Role of Regulatory Compliance in Pharmaceutical Product Development

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  Introduction Navigating the complex landscape of pharmaceutical product development requires a deep understanding of regulatory compliance. At Purology, we believe that regulatory compliance isn't just a checkbox—it's the foundation of a successful pharmaceutical product lifecycle. In this blog, we’ll explore the critical role that regulatory compliance plays in ensuring the safety, efficacy, and market readiness of pharmaceutical products. Understanding Regulatory Compliance Regulatory compliance is the process of adhering to laws, guidelines, and specifications relevant to your business processes. For pharmaceutical companies, this involves strict adherence to regulations set by authorities like the FDA, EMA, and MHRA. Non-compliance can lead to significant setbacks, including product recalls, fines, and damaged reputations. That’s why at Purology, we prioritize staying ahead of regulatory changes and ensuring our clients are always in full compliance. The Importance of Ear...
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