Precision Peptide CMC Rooted in Analytical Excellence
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At Peptide Pundit, we empower you. Helping navigate the complex landscape from pre- clinical feasibility and IND, to NDA/ANDA or DMF filings required for market approval. Our expert consulting services cover every essential aspect, from scale-up and CMC to phase appropriate regulatory compliance. Trust us to guide you through the intracacies inherant to Peptide API manufacturing processes.
Ensuring your product is primed for a successful market launch. Your vision deserves the right support, and we are here to provide it.
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Unlike large firms that often provide templated advice, Peptide Pundit offers boutique, high-touch expertise. We act as an extension of your internal team, providing unbiased oversight of your CDMO partners to ensure they are meeting your specific quality and timeline milestones without scope creep.
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Yes. We offer comprehensive technical writing and review for Drug Master Files (DMF), Investigational New Drug (IND) applications, and Marketing Authorization Applications (MAA). We ensure your Module 3 (Quality) documentation is audit-ready and meets current FDA/EMA expectations.
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While we can step in at any stage, early engagement during the Lead Optimization or Pre-clinical phase provides the highest ROI. Establishing a "Quality by Design" (QbD) framework early prevents costly process re-validations and regulatory hurdles during Phase II and III.
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Absolutely. Transitioning from "bench to batch" is where most peptide projects face yield and purity drops. We specialize in process intensification and tech transfer, ensuring that your lab-scale successes are economically and technically viable at a commercial GMP scale.
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We provide tailored CMC roadmaps that address the unique challenges of each path—focusing on solid-phase synthesis (SPPS) optimization and impurity profiling for synthetics, or upstream yield and downstream purification scalability for recombinant processes. Our goal is to ensure your regulatory filings (IND/NDA) are robust from day one.
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Chemistry, Manufacturing, and Controls (CMC) requirements are essential for peptide drugs to ensure product quality, safety, and efficacy. This includes detailed documentation of the drug's chemical composition, manufacturing processes, quality control measures, and stability testing. Startups must understand these requirements to comply with regulatory bodies, such as the FDA. Our expertise in CMC helps clients navigate the complexities of regulatory submissions, ensuring that all necessary information is gathered and presented effectively, paving the way for successful drug approval.
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Regulatory requirements play a crucial role in peptide drug development, dictating the necessary steps for clinical trials and market approval. These requirements ensure that drugs meet safety and efficacy standards before reaching patients. Startups must navigate a complex landscape of guidelines and submissions, including Investigational New Drug (IND) applications and New Drug Applications (NDA). At Peptide Pundit, we provide tailored consulting support to help companies understand and fulfill these requirements efficiently, reducing time to market and enhancing the likelihood of success.
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Scale-up in peptide drug development refers to the process of increasing production from laboratory scale to commercial scale while maintaining product quality and efficiency. This involves optimizing manufacturing processes, ensuring compliance with Good Manufacturing Practices (GMP), and validating methods to meet regulatory requirements. Startups often face challenges during scale-up, including managing costs and maintaining consistency in product characteristics. Our consulting services guide companies through this critical phase, helping to mitigate risks and streamline operations for successful market entry.