Transform complex regulatory requirements into a clear, science-driven roadmap with integrated testing, regulatory strategy, and dossier development services designed to accelerate global market approval.
Regulatory Strategy & Dossier Development helps companies navigate complex regulatory requirements and generate the scientific evidence needed for successful product approval. BaseClear supports clients from the earliest stages of regulatory planning through dossier preparation and post-submission support, translating regulatory expectations into a clear, actionable development roadmap. The service is designed to reduce regulatory uncertainty, identify data requirements early, and ensure that studies are aligned with the expectations of authorities such as EFSA, FDA, NHC, and other global regulatory agencies.
This service is intended for companies developing microbial-derived products for food, feed, biotechnology, and industrial applications. Typical projects include probiotics, postbiotics, food enzymes, feed additives, fermentation products, microbial ingredients, and products derived from genetically modified production strains. Whether a client is preparing a first regulatory submission or expanding into new international markets, BaseClear provides the strategic guidance needed to define the most efficient regulatory pathway and avoid unnecessary studies or delays.
BaseClear combines regulatory consulting with integrated laboratory and scientific expertise. The process begins with product classification, regulatory gap analysis, literature review, and identification of required studies. Depending on the project, this may include whole genome sequencing for strain characterization, antimicrobial resistance assessment, viable cell testing, residual DNA detection, antimicrobial activity testing, cytotoxicity studies, and coordination of additional studies through qualified partners. Scientific findings are interpreted within the regulatory framework and assembled into a coherent safety narrative that supports the intended application and market.
Clients receive a comprehensive regulatory strategy package tailored to their product and target market. Deliverables may include a regulatory roadmap, study plans, scientific gap assessments, expert interpretation of results, dossier-ready reports, and support with dossier compilation and submission. BaseClear can also assist with authority questions, supplementary studies, technical clarifications, and post-submission interactions, providing continuity from early development through regulatory approval and market access.
Discuss your product, target markets, and regulatory objectives with our specialists. Together, we determine the most appropriate regulatory pathway and identify potential challenges early in the process.
We evaluate your existing data package and identify any scientific, safety, or regulatory gaps. You receive a clear roadmap outlining the studies and documentation required to support your submission.
Where additional data are required, BaseClear coordinates and performs the necessary studies, including strain characterization, antimicrobial resistance assessment, product verification, and other regulatory safety evaluations.
Our regulatory and scientific experts compile the results into a structured, submission-ready dossier. Scientific findings are translated into a clear safety narrative aligned with the expectations of the relevant regulatory authority.
Once submitted, we support you with technical clarifications, authority questions, supplementary data requests, and ongoing regulatory interactions to help keep your project moving forward.
End-to-end microbial safety assessment capabilities
Regulatory-ready data generation and interpretation
Integrated wet-lab and bioinformatics expertise
Structured support for EFSA and global submissions
Regulatory strategy should be defined as early as possible, ideally before key development and safety studies are started. Early planning helps determine the applicable regulatory pathway, identify data requirements, and avoid studies that may not meet authority expectations. For microbial products, early strategy is especially important because strain characterization, safety testing, production process information, and final product data must be aligned from the beginning.
A regulatory gap analysis assesses whether the available data are sufficient to support a future submission. This typically includes review of strain identity, WGS data, AMR assessment, toxigenic potential, viable cells, residual DNA, product characterization, study reports, and intended use. The outcome is a clear overview of missing information, potential regulatory risks, and recommended next steps before dossier preparation.
Existing data can be used in a regulatory dossier if they are scientifically robust, relevant to the product, and aligned with current regulatory expectations. However, older studies or reports may need additional justification, re-interpretation, or supplementary testing, especially when guidance has changed. A regulatory review helps determine whether existing data can be used directly or whether additional studies are needed.
A strong regulatory strategy reduces delays by ensuring that the dossier is complete, coherent, and supported by appropriate scientific evidence. Many delays occur because of missing strain information, unclear study design, insufficient interpretation of WGS or AMR data, or lack of justification for safety conclusions. By identifying these issues before submission, the risk of additional questions, clock stops, or requests for new studies can be reduced.
BaseClear supports dossier development by integrating all relevant scientific, technical, and regulatory information into a coherent submission package. This includes reviewing existing data, identifying gaps, planning additional studies where needed, interpreting results, drafting dossier sections, and preparing regulatory justifications. The aim is to ensure that the full dossier is scientifically consistent, regulatory-aligned, and ready for authority review.
SERVICES
Phenotypic assessment of antimicrobial resistance aligned with EFSA guidelines
SERVICES
Phenotypic assessment of antimicrobial and cytotoxic production
Speak with our experts to design a WGS strategy aligned with your regulatory needs. Your first consultation is free and without obligation.
