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
Company Details
- Employees
- 1
- Founded
- -
- Address
- Perumbakkam 1st Main 1st Cross Street, Sholinganallur,chennai,tamil Nadu 600100,india
- Industry
- Information Services
- NAICS
-
Other Information ServicesNews SyndicatesAll Other Information Services
- Keywords
- Sholinganallur.
- HQ
- Sholinganallur, Chennai, Tamil Nadu
- Competitors
- DAK Health care consultancy, Richmond Market Research and Advisory, SciCord, Vesoftometic Solution Private Limited, LSC - LifeSciences Consultants, Biotech & Life Sciences Consultant, Grace Pharma Consultancy Services, Catalyst LifeSciences Private Limited, DR YELLAPRAGADA LIFESCIENCES, Bot Bridge Technologies Pvt Ltd.
Biofidel Life Sciences Consultancy Questions
Biofidel Life Sciences Consultancy's website is http://www.biofidellifesciences.com/
Biofidel Life Sciences Consultancy's LinkedIn profile is https://in.linkedin.com/company/biofidel-life-sciences-consultancy
Biofidel Life Sciences Consultancy has
1 employees.
View email and phone details for 1
employees at Biofidel Life Sciences Consultancy.
Biofidel Life Sciences Consultancy's industry is
Information Services
Biofidel Life Sciences Consultancy's top competitors are
Dak Health Care Consultancy,
Richmond Market Research And Advisory,
Scicord,
Vesoftometic Solution Private Limited,
Lsc - Lifesciences Consultants,
Biotech & Life Sciences Consultant,
Grace Pharma Consultancy Services,
Catalyst Lifesciences Private Limited,
Dr Yellapragada Lifesciences,
Bot Bridge Technologies Pvt Ltd.
Biofidel Life Sciences Consultancy's categories are Information Services
Biofidel Life Sciences Consultancy's founding year is 2023
