Here at Ethixinn CRS, we are focused to provide practically implementable, cost effective and innovative research solutions in compliance with global Quality standards and Regulatory requirements. Our team with excellent troubleshooting skills and proven track record is well-versed with current Scientific, Quality as well as Regulatory practices and capable of providing time-tested research solutions for various research puzzles with desired quality and regulatory standards within stipulated time.

Our innovative solutions include assistance and advice to our esteemed customers and eminent partners by using our standard and customized solutions. With vast exposure of 500+ Bioanalytical Assays, 1000+ BE/DDI and a few Phase-I studies, 30+ international regulatory inspections and 500+ sponsor’s audits. Further, out of our strong instinct of serving the global scientific community, 300+ GCP inspectors for BA/BE inspections, 1000+ GCP/GLP research professionals and 500 chemists/senior chemists for NABL testing labs have been trained in Pharm R&D and Environmental Research. Ethixinn CRS is capable of providing the strong research support which is convincingly backed up with 50+ peer reviewed international research publications.

Technical Consultancy Services

Green-field project Services

  • CROs, BA/BE Centre, Labs and QMS
  • Inception to Inspection – Pre-clinical, BA/BE, Bioanalytical Lab, Water Testing Lab & Quality Management
  • GCP-GLP Compliant BA/BE Centre
  • GLP-GCLP Compliant Bioanalytical Lab – Small & Large Molecules
  • NABL/GLP Accredited Water Testing Lab
  • Develop or Fine-tune the GCP-GLP / ISO / NABL Compliant QMS
  • Creating CRO Project report
  • Develop or fine-tune infrastructure for Labs, Clinics and CROs
  • Hire suitable employees for Key Resource Centres
  • Train the employees & managers for technical operations, quality, audits, regulations

Our experience in handling global bio-studies and understanding regulatory requirements works to your advantage as we can ensure timely volunteer enrolment, quality analytical data and efficient study completion. Our QMS and processes are compliant with ICH-GCP guidelines, GLP/GCLP Principles, all local regulatory requirements and current industry standard.

  • BA/BE, Patient Trials, Bio-waivers studies & Bioanalysis Tech Support
  • Advising Vendor / CRO Selection
  • Advising the Bio-study Design, Standardization, Conduct, Compliance, Archiving & Reporting
  • In-vitro and In-vivo Correlation (IVIVC) services with F1/F2 compliance evaluation & resolution services
  • Devising Strategies and approaches for successful BA/BE studies
  • Pre- and Post-study Reviews (Protocols, Reports, Raw data and Events)
  • Failure Investigations, Root Cause & Impact analysis and CAPA with fully compliant report
  • Responding Regulatory bio-deficiencies, queries & issues
  • QMS related modifications based on CAPA in response to bio-deficiencies
  • Auditing (Standard / Investigational)
  • Monitoring (In-process / Retrospective)
  • Training School on “Bioequivalence & PK studies”
  • End to end training support for budding and seasoned scientists

  • Establishment, Production & Testing (In-Vitro, Pre-clinical & Clinical Trials)
  • Quality & regulatory Services – Approvals, Licenses & NOCs

Our highly qualified and experienced scientists have an accumulated experience of 1000+ validated methods.

Our vast expertise and in-depth understanding of the stringent scientific, quality and regulatory requirements ensures each project is accomplished in rapid turn-around times each and every time.

  • Method Development and Validation for proprietary (NME) and non-proprietary assays
  • Method Transfer and Method Validation – EMA, USFDA etc.
  • Expertise in guiding to develop and validate highly sensitive assays in sub pg/mL or fg/mL
  • Guiding on approaches for Robust Bioanalytical Methods
  • Quantify small/large molecules in biological matrices (healthy human, patients and animals)
  • Pre and Post studied Reviews (Protocols, Reports, Raw data and Events)
  • Failure Investigations, Root Cause & Impact analysis and CAPA with fully compliant report
  • Responding Regulatory bio-deficiencies, queries and outstanding issues.
  • Guiding for QMS related modifications based on CAPA in response to bio- deficiencies.
  • Audits (Standard, Vendor Qualification, Investigational) & Monitoring (Routine & Risk based).
  • End to end training support for budding and seasoned scientists/chemists
  • Standard and Customised Training School for Bioanalytical professionals – for Method Development, Method Validation and Project sample analysis and Trainer

  • Building / Refining the QMS for Labs / CRO / R&D Centre
  • Standard / Investigational Audits for PK, Bioanalytical, Clinical and BA/BE
  • Advising the clients for Reviews, Root Cause & Impact Analysis and CAPA
  • Assisting the clients for trigger and face the regulatory inspections / third-party audits successfully
  • Assisting clients to submit dossiers to international regulatory agencies for marketing authorization
  • Assisting industry/regulatory agencies to train their staff

  • Concept To Compliance GCP-GLP Compliant establishment, review and Quality enhancement services
  • Desktop Surveillance Audit (virtual) or Investigational Audit (Onsite)
  • Data Integrity Issues Avoidance Strategy – DIIAS Services
  • Process Efficiency Services – Process Mapping, Gap Analysis & Efficiency enhancement
  • Bio-IT Services – Digital Transformation of CRO/Lab processes, CSV and 21CFR Part11
  • Business Development for pharma, clinical, lab and environmental research
  • End to end Project Management for drug development
  • Research Paper Publications – in International peer review journals

Audits / Monitoring / Review Services

“Assist Clients for Triggering the Regulatory GxP Inspections” – USFDA, EMA, WHO, ANVISA

Audit Services

  • Third Party Preparatory AUDITS – CROs, CMOs
  • Qualification Audits – Vendors, CROs & QMS.
  • Investigational Audits – Investigations, OOS & Unforeseen Results (Specialized Service).
  • Assist Clients to Respond and close the Various Regulatory Inspection Related Queries.
  • User, Monitor and regulator friendly and fully compliant quality management system for monitoring.
  • Standard monitoring system, SOP, agenda, plan and reports.
  • Capable of customise the need based monitoring system, check list and reports.

Auditor’s demography:

  • +5 Years experienced monitors are eligible for any audit at Ethixinn CRS.
  • Well-versed with all kinds of studies / audits
  • Experienced auditors @ Gujarat, Maharashtra, Telangana, Delhi NCR and MP.

  • One-stop solution for BA/BE, patient PK and clinical trial monitoring – Centralised Monitoring, Risk based Monitoring, Need based monitoring
  • Well-versed and offer all prevailing monitoring methods / modes – On-site, On-line, In-process & Retrospective Monitoring (remote/Physical)
  • Desktop Monitoring for budget clinical trials
  • An independent Monitoring visit consists of; Site Qualification visit, Site initiation visit, interim monitoring visit / retrospective, investigational monitoring visit & close-out monitoring visit
  • Assist Clients to Respond and close the Various monitoring Related Queries.
  • User, Monitor and Regulator friendly and fully compliant quality management system for monitoring.
  • Standard Monitoring system, SOP, Agenda, Plan and Reports.
  • Capable of customise the need based monitoring system, check list and reports.

Monitor’s demography:

  • +5 Years experienced monitors are eligible for any monitoring at Ethixinn CRS.
  • Well-versed with all kinds of dosage forms and dosings
  • Experienced monitors @ Gujarat, Maharashtra, Telangana, Delhi NCR and M.P.

  • Organization Specific Review – Infrastructure, Resources, QMS, Process, Personnel
  • Activity / Event Specific Review – Methods, Tech./Method Transfer, MD, MV, Sample Analysis, Policies, Processes, Personnel, Biostudy PROTOCOLs, Data & Reports
  • Failure Investigations Strategy – Design, Conduct & Conclusion-Specialized service
  • Failure Investigations Process –Root Cause & Gap Analysis, Impact Analysis & CAPA

TRAININGS

“If you think training is expensive, try ignorance”

Continuous education, training and regular updates on science, quality and regulatory in the space of Pharma research, Drinking Water, Waste Water, Sanitation, Solid waste, Air; and Lab Testing, Operations & Maintenance (O&M) and Quality Management will aid to survive and further boost the performance of a Key Resource, Testing Lab, Research Centre / CRO. We offer wide range of training programs designed by research and industry leaders for industry professionals and fresh college pass-outs to fulfil the standard and specific requirements as well.

Continuous Education, Training & Updates; helpful to; Survival, Performance Booster, Continuous growth. Standard and need based Training Programs are designed by research and industry leaders for Research Professional & Scholars.

Training & Mentoring Services

  • BA/BE Workshop (Authorized by WHO, Geneva)
  • Method Development (MD) Workshop
  • Clinical & GCP Workshop
  • Auditor’s / Monitor’s / Trainer’s Training Workshop

  • GCP,
  • GLP / GCLP
  • GMP

  • Analyst – ‘The ArjunA” – 6 Weeks Course
  • Group Leader – “The Dronacharya” – 2 Weeks Course
  • Tied up with professional CROs for hands-on Training
  • Online Training courses to develop Bioanalysis Expert

Water testing Laboratory Accreditation Programme (NABL, ISO, GLP) Training Workshop – Basic (2 Day) & Advanced  (4  Days)

Water testing Workshop – Testing, Equipment Qualification and Staff Training – Basic (2 Day) & Advanced  (4  Days)

Waste Water, Sanitation and Solid Waste Management Workshop – Testing, Quality Management & Staff Training (2 Day) & Advanced  (4  Days)

Combination of Theory (30%) and Practical (70%) Training. Specific training courses designed for industry professionals and students. Facilities and Guidance for Dissertation work for MS and PhD of Analytical and Bioanalytical Science. Standard Training Courses: 6 Months, 3 Month and 4 Weeks.