Dossier Preparation
RSA offer expert dossier preparation services designed to streamline the regulatory approval process. Our experienced team ensures that all necessary client documentation is compiled, reviewed, and submitted according to the specific requirements.
Dossier Preparation Services
Data gap analysis
RSA can review data for technical completeness against the data requirements detailed in Commission Regulations (EU) No 283/2013 and 284/2013, associated guidance documents, relevant scientific opinions and any vulnerability to classification under the CLP Regulation ((EU) No 1272/2008). Any findings of concern can be highlighted as well as the need for additional toxicology studies, where relevant, and a testing strategy can be recommended.
Risk Assessment
RSA specialists are experienced in performing both human health and environmental assessments. With a broad range of toxicological, testing and regulatory expertise, as well as experience with alternative methods (in vitro, in silico, QSAR and read-across) and literature searching, our experts can offer guidance on the hazard and risk of chemicals.
Study Summaries (OECD and IUCLID)
Preparation of summaries, both of study reports and literature papers, is a crucial part of dossier preparation. RSA can help prepare OECD, OHT, IUCLID and DER summaries. All summaries are peer reviewed for quality and consistency ready for inclusion in submission documents.
CRO Liaison
From selecting the right CRO, designing a robust study plan, through to data interpretation and reporting, the RSA study monitoring team have the experience necessary to advise on any issue, ensuring that our clients are kept informed and have confidence that their studies are being monitored to the highest standards.
Literature Searches
RSA is experienced in performing and documenting systematic literature searches according to EFSA Guidance, including assessment of published literature for relevance and reliability.
Dossier Preparation Specialists
Our Team
RSA's world-class consultants are committed to providing you with the support that will address and resolve complex issues and achieve regulatory compliance.
Our Team >
Sectors we work with
Pharmaceuticals >
Agrochemicals >
General Chemicals >Blog
Meet The Team – David Andrew
Reviewing the thoroughness of human safety testing for succinate dehydrogenase inhibitors: fluopyram as a case study
Applicability of kinetically-based maximum dose studies for hazard and risk assessments of the fungicide fluoxapiprolin
Dossier Preparation Services FAQ's
RSA provides dossier preparation services to the pharmaceutical, agrochemical, biocides and general chemical industries.
RSA specialists can prepare high-quality OECD, OHT, IUCLID and DER study summaries. All study summaries are peer reviewed to ensure accuracy, consistency and readiness for inclusion in submission dossiers.
Yes, our specialists can conduct both human health and environmental risk assessments in compliance with the latest guidance for inclusion in submission dossiers.
Yes, RSA performs systematic literature searches in accordance with current guidance, including the assessment of studies for relevance and reliability.
All dossier components prepared by RSA’s dossier preparation specialists undergo internal technical review and quality checks to ensure compliance with regulatory guidance and consistency across the dossier.
Yes, we routinely address authority comments, data requests and clarifications during the dossier evaluation phase, helping keep the submission process on track.