Non-Clinical Regulatory Writing

At Masuu Global, we excel in Non-Clinical Regulatory Writing, offering an extensive range of services to support our clients in the pharmaceutical industry. Our experienced team ensures the preparation of meticulously crafted non-clinical documents that meet the stringent requirements of regulatory authorities, facilitating the approval process. We support the clients for Generic, Hybrid and Bibliographic applications for global markets i.e. USA, EU and RoW. Below are the detailed services we offer

• Module 2.4 – Non-Clinical Overview:
  We prepare comprehensive non-clinical overviews (M 2.4) that summarize the pharmacological, pharmacokinetic, and toxicological data based on literature references in Module 4 (Non-Clinical) and studies.
• Module 2.6 – Non-Clinical Summaries:
  Our team develops detailed non-clinical summaries (M 2.6), including summaries of the pharmacology, pharmacokinetics, and toxicology studies based on literature references in Module 4 (Non-Clinical) and studies.
• Data Integration:
  We ensure seamless integration of non-clinical data into the regulatory submissions, providing a cohesive and comprehensive overview of the investigational product.

• Thorough Assessments:
  We conduct thorough environmental risk assessments to evaluate the potential impact of pharmaceuticals on the environment.
• Regulatory Compliance:
  Our assessments adhere to the regulatory guidelines of major authorities, ensuring compliance and acceptance.
• Mitigation Strategies:
  We propose mitigation strategies to address and manage potential environmental risks associated with the use and disposal of pharmaceuticals.

• Expert evaluation of genetically modified organisms (GMO) and non-GMO substances
• Comprehensive analysis to determine toxicological profiles and regulatory implications

• Calculation of PDE values based on toxicological data and regulatory guidelines.
• Ensuring compliance with safety standards for pharmaceutical manufacturing and handling.

• Establishment of OELs to protect workers from exposure to hazardous substances.
• Utilization of scientific data and regulatory frameworks to set appropriate exposure limits.

• Classification of substances into OEB categories to manage occupational exposure risks.
• Application of toxicological expertise to assign substances to the appropriate exposure band.

• Evaluation of substances for GRAS status according to regulatory requirements.
• Preparation of scientific dossiers to support GRAS determinations for food additives and ingredients.

• Expertise and Experience:
  Our team comprises experienced professionals with extensive knowledge in non-clinical regulatory writing.
• Quality Assurance:
  We follow stringent quality assurance processes to ensure the highest standards in our documentation.
• Client-Centric Approach:
  We focus on understanding our clients’ needs and providing customized solutions that meet their specific requirements.
• Global Reach:
  Our services are designed to cater to the needs of clients across the globe, ensuring their success in diverse markets.
• Rigorous Research:
  Our non-clinical documents are based on thorough research and analysis, ensuring scientific accuracy and reliability.
• Expert Review:
  All documents undergo rigorous review by experts to ensure they meet the highest scientific standards.
• Comprehensive Documentation:
  Our meticulously crafted non-clinical documents ensure a smooth and efficient approval process.
• Regulatory Liaison:
  We assist in liaising with regulatory authorities, addressing queries, and providing additional information as required.
• Adherence to Guidelines:
  Our team is well-versed with the guidelines of major regulatory bodies, including the FDA, EMA, and others.
• Up-to-date Practices:
  We stay updated with the lawww regulatory requirements and practices, ensuring our documents are always compliant.
• Client Success:
  Our meticulous documentation and regulatory support contribute significantly to the successful approval and market entry of our clients’ products.
• Ongoing Support:
  We provide ongoing support throughout the regulatory process, ensuring our clients achieve their goals.

With Masuu Global, you can be confident that your non-clinical regulatory documents will be meticulously prepared, scientifically accurate, and fully compliant with all relevant regulations, paving the way for your success in the pharmaceutical industry.