Regulatory Literature Review Services

Regulatory and Technical Support for systematic Review of Literature and Scientific Assessment: 

In the ever-evolving landscape of regulatory compliance, a comprehensive scientific evaluation is essential to guarantee the safety and effectiveness of chemical goods that are introduced into the market. Strict laws, especially in the European Union (EU), require a thorough assessment of possible risks, with an emphasis on endocrine disruptors (ED) and other toxicological concerns. Businesses must have dependable and thorough assistance when performing systematic literature studies and scientific evaluations as they attempt to navigate this challenging regulatory landscape.

Auxilife Scientific Services Pvt. Ltd. emerges as a beacon of expertise in this regulatory journey, offering specialized technical and regulatory assistance tailored to meet the rigorous demands of EU regulations and beyond. With a profound understanding of the intricacies involved in evaluating chemical safety, our team stands ready to provide unparalleled support in the systematic review of literature and scientific assessment processes.

A. Endocrine Disruptor Assessment:

In compliance with EU Regulations such as Commission Regulation (EU) No 2018/605 and the Joint Guidance published by ECHA/EFSA, Auxilife is equipped to conduct comprehensive literature reviews to identify the toxicity of chemicals, particularly focusing on endocrine disruptors (ED). Our systematic approach involves:

  • Database Selection: We meticulously select the most relevant databases to ensure a thorough literature search, avoiding the omission of any pertinent information.
  • Hit Scanning and Quality Checks: Our team carefully scans the search hits to identify relevant literature that fits the ED assessment criteria. Additionally, we employ software tools for quality checks on abstracts and articles to ensure relevance and reliability.
  • Full Article Provision: We provide access to full articles for your reference, facilitating a deeper understanding of the identified literature.
  • Standard Report Preparation: Auxilife prepares standard reports incorporating all relevant information for submission to regulatory authorities, including the completion of Appendix E for ED assessment.
  • Lines of Evidence (LoE) Development: We draw LoE in line with Estrogen, Androgen, Thyroid, and Steroidogenesis (EATS) criteria, facilitating a structured scientific assessment.
  • Final Report Preparation: Our team conducts a comprehensive scientific assessment and prepares a final report for the identification of ED, ensuring compliance with regulatory requirements.

B. Literature Search Services in other areas:

A robust literature search is fundamental for developing research questions, planning studies, and justifying project worthiness. Auxilife extends its expertise in conducting literature searches for various purposes, including:

  • Ecotoxicity and Toxicity Assessment: We specialize in evaluating the ecotoxicity and toxicity of chemicals, pesticides, and biocides, providing essential data for regulatory compliance.
  • Hazard Identification: Our team conducts literature searches to identify hazards associated with chemicals, enabling informed decision-making in product development and usage.
  • Classification and Labelling Support: Our expertise extends to assisting in the accurate classification and labelling of your biocidal products through thorough literature reviews, ensuring alignment with regulatory standards.
  • Weight of Evidence for Registration: : Auxilife provides weight of evidence for the registration of biopesticides, supporting regulatory submissions with comprehensive literature reviews.
  • Justification of Chemical Usage: We offer literature search services to justify the usage of chemicals or application methods, enhancing the transparency and credibility of regulatory submissions.

 

KEY LITERATURE REVIEW SERVICES

 

  • Identifying relevant databases for searching scholarly articles
  • Optimizing relevant keywords for effective data search
  • Extracting data from target databases based on identified keywords
  • Removing redundant information through the eduplication process
  • Swiftly assessing target potential through relevance filtering
  • Analysing key information extracted from abstracts comprehensively
  • Thoroughly examining full-text articles for comprehensive data extraction
  • Filtering for relevance and conducting detailed assessments to meet objectives
  • Summarizing and organizing retrieved information
  • Preparing summary reports efficiently

 

We, at Auxilife, specialize in offering regulatory and technical assistance for tailored systematic literature reviews and scientific assessments, catering to the unique needs of clients spanning various industries. Leveraging our technical proficiency, extensive experience, and strict adherence to EU regulations and guidelines, we guarantee thorough and dependable evaluations of chemical substances. Our services empower businesses to effectively navigate regulatory frameworks and uphold compliance with stringent standards.