Domain depth where compliance risk is highest.
Rishi Biotech operates across regulatory affairs, clinical data, pharmacovigilance, and biotech quality — not as a generalist curriculum, but as a specialist practice built around the workflows your teams will actually use.
Pharmaceutical companies, CROs, and biotech firms operate in sectors where a compliance gap is not an inconvenience — it is a legal and operational liability. In-house specialists are expensive to build; external generalists do not reduce risk.
Built for the gap academic training leaves open.
Rishi Biotech was structured to fill that space — professional services and industry-oriented training grounded in the same regulatory frameworks, data structures, and filing processes your organization faces in practice.
Nine tightly defined areas of practice.
Each domain represents a discrete body of regulatory, technical, or operational knowledge — delivered as professional services to organizations and as hands-on training to practitioners.
Bioinformatics
Clinical Data Management
Clinical Data Analytics
Sequence analysis, genomic data pipelines, and computational biology workflows aligned to research and clinical application standards.
Protocol-driven data collection, CDMS configuration, and audit-ready study database management for CROs and sponsors.
Statistical programming, CDISC-compliant data transformation, and reporting pipelines that turn raw trial data into submission-ready evidence.
Regulatory Affairs
Medical Devices
Pharmacovigilance
IND, NDA, and MAA dossier preparation, agency correspondence strategy, and post-approval change management across FDA and ICH frameworks.
Technical file assembly, 510(k) and CE-mark regulatory strategy, quality system documentation, and post-market surveillance planning.
Safety database operations, ICSR processing, PSUR authoring, and signal detection workflows built to current EMA and FDA reporting standards.
Real World Evidence
Biotechnology & Life Sciences
Food Safety & Quality Assurance
RWE study design, claims and EHR data curation, comparative effectiveness analysis, and regulatory-grade evidence packages for payer and agency submissions.
Process development documentation, GMP gap assessments, cell and gene therapy regulatory support, and CMC section preparation for biologics filings.
HACCP plan development, FSMA compliance programs, supplier audit frameworks, and quality management system documentation for food and nutraceutical manufacturers.
Process knowledge that only comes from doing it repeatedly.
The same regulatory workflows, filing structures, and data review processes your teams will encounter — applied by practitioners who have worked through them across real submissions, not simulated scenarios.