BioFidel Life Sciences Consultancy

BioFidel Life Science is a privately-owned company dedicated to offering consultancy and outsourcing solutions for the comprehensive spectrum of tasks, sub-tasks, transactions, operations, and all endeavors conducted by highly regulated Life Sciences, Pharma, Preclinical, CRO, and Chemical sectors worldwide. The service portfolio encompasses processes and sub-processes that are facilitated by information technology, such as, - End-to-end preclinical digital technology solutions & transformation - Preclinical study data management process optimization - Business analysis and implementation of digital lab systems - EDC, ELN, LIMS, RIMS, and QMS - Nonclinical data management (ETL and DMS) - Data visualization, analytics - OECD-GLP compliance monitoring and audits - Establishment of in-house/outsourcing CDISC-SEND services - Nonclinical SEND creation (full conversion) - SEND QC/verification and error fixes - SEND validation and error fixes - SEND education (onsite/virtual) - SEND consultancy - Pharma Regulatory Submission Support - Nonclinical TOC (eCTD Module 2) - Nonclinical summary writing (eCTD Module 2) - Investigator brochure (IB) writing (eCTD Module 2) - IND, NDA, ANDA, BLA submission to FDA (CDER/CBDER) - Computer System Validation (CSV) and IQ, OQ, & PQ documentation - Medical devices risk assessment and compliance - PDE, and OEL derivation - Impurity Assessments - Extractables and leachables safety assessments - Chemical Regulatory Advocacy - Product stewardship and chemical regulatory advocacy services - Hazard assessment - Hazard classifications of chemicals as per GHS, CLP, & HazCom - EU-REACH registration support - IUCLID dossier preparation - Chemical toxicity profiling and safety evaluations - Risk assessment and literature search