Regulatory Service

Regulatory services
  • ICBio being one of the best CRO in India provides regulatory services to facilitate all stages of drug development. We accomplish this by providing interdisciplinary strategy planning to obtain the most effective and efficient regulatory pathway towards regulatory authorizations. Till now, we have achieved a 100% success rate of regulatory approvals in equipping regulatory affairs.
  • We provide a wide range of Regulatory Writing Services and project management services covering key therapeutic areas across clinical and post marketing stages.
  • We compile, organize, write, and edit a range of high-quality regulatory and safety documents that include clinical development plans, study protocols, investigator brochures, informed consent documents, pre-clinical and clinical study reports, common technical documents, safety narratives, and aggregated reports (PSURs, NDA PRs) which are regularly followed in clinical trials services in India.
  • Our regulatory writing, regulatory dossiers and safety services are cost-effective, flexible, and seamlessly integrated with the needs of various regulators and clients across the world.
  • Our regulatory affairs in pharma industry help the pharmaceutical companies to ease the different stages of drug development. The regulatory affairs pharmaceutical industry provides the effective services of pharmaceutical, biologic and medical device product development and the other management.
We do offer :

Dossier compilation as per:

  • Asean Common Technical Dossier (ACTD) Guidelines
  • Common Technical Dossier (CTD) Guidelines
  • Drug Master File (DMF)

Drafts data for:

  • BMR, MFR
  • Process Validation
  • Analytical Validation
  • Stability Study reports
  • Dissolution profile
  • Certificate of analysis and related reports

Compilation of:

  • Justification for fixed dose combination
  • Prepare Periodic Safety Update report (PSUR)

Prepare Summary of:

  • Summary of Product Characteristics (SmPC)
  • Patient Information Leaflet (PIL)
  • Label and carton content
  • Product Development

Overviews (Module 2):

  • Clinical
  • Non Clinical

Non Clinical Study Reports (Module 4)

Clinical Study Reports (Module 5)

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Quality Assurance
Quality management provides quality systems which in turn guarantee good quality data in each clinical trial. Quality systems implemented at ICBIO and managed by Quality Management ensure the quality, integrity, and accuracy of data for each clinical study undertaken at ICBIO.

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Clinical Development
Clinical Development team conducts Phases II-IV clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. A team of well-trained professionals, experience in project management in various therapeutic areas.

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Bio Analytical
ICBio management & operations team brings in considerable experience in conducting BA/BE studies on healthy as well as patient population with various dosage forms including injectables like IM/IV/SC, oral dosage forms like solid formulations (Modified Release preparations), liquid formulations, topical preparations and inhalations. The BA/BE studies conducted at ICBio are fully GCP compliant.

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Project Management
ICBIO's project management group stands out from other CROs in an industry where hard deliverables and quality of enrollment are everything. ICBIO project managers throughout the globe are obsessive about on-time project delivery from day one.

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Our focus is to ensure the integrity of your data and organize your findings and conclusions into a clear and results-oriented presentation. Our bio statistics for clinical research and statistical programming services include pre-analysis, analysis and post-analysis.

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