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info@visionofresearch.ae

14th Floor, Dubai Science Park South Tower - Al Barsha South - Dubai - UAE

+971 425 44824

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Academic & Research Platforms

University & Discovery-Oriented Services

1.End-to-End Research Project Design

2.Scientific Positioning & Topic Strategy

3.Hypothesis & Research Question Engineering

4.Study Methodology & Experimental Workflow

5.Statistical Design & Power Analysis

6.Biomarker, Gene & Target Strategy

7.Assay Selection & Validation Planning

8.Translational & Regulatory Alignment

9.Risk Management, Quality & Reproducibility

10.Data Analysis, Reporting & Scientific Support

1.Neurology & Neuroscience

2.Metabolic & Endocrine Models

3.Cardiovascular & Stroke Models

4.Reproductive & Fertility Models

5.Immunology & Inflammation

6.Liver & Kidney Disease Models

7.Gastrointestinal & Microbiome

8.Regenerative & Wound Healing

9.Toxicology & Safety Models

10.Ocular & Retinal Disease Models

11.Respiratory Disease Models

12.Musculoskeletal & Arthritis Models

13.Urology & Renal Function Models

14.Ocular & Retinal Disease Models

1.Learning, Memory & Cognition

2.Anxiety & Stress Behavior Assessment

3.Depression & Motivation Behavior

4.Pain & Nociception Assessment

5.Motor Function & Coordination

6.Sensorimotor Integration & Reflexes

7.Seizure & Epilepsy-Related Behavior

8.Sleep & Circadian Rhythm

9.Social Behavior & Communication

10.Reward, Addiction & Motivation

11.Fatigue & Exercise Capacity

12.Gastrointestinal & Feeding Behavior

13.Metabolic & Energy Balance

14.Urinary & Bladder Function

15.Cardiovascular Function & Stroke

16.Regenerative Functional Readouts

17.General Activity, Locomotion

Clinical Monitoring

  • General Appearance & Condition
  • Behavior & Stress Indicators
  • Grooming & Coat Condition
  • Respiratory Patterns & Function
  • Toxicity & Distress Signs
  • Body Weight & Growth Monitoring
  • Food Intake & Nutritional Status
  • Hydration & Fluid Balance

Hematological & Biochemical

  • Complete Blood Count (CBC)
  • Clinical Biochemistry Panels
  • Electrolyte

1.Gene Expression (PCR-based)

2.Nucleic Acid Extraction & Synthesis

3.Design of Nucleotide Primer Sequences

4.PCR & Advanced Molecular Analysis 

5.DNA & RNA Quantification

6.Agarose Gel Electrophoresis Performance

7.Epigenetic and DNA Methylation Assays

8.Transcriptomic and RNA-Seq Analysis

9.CRISPR-Based Genetic Validation Assays

10.Protein Expression (WB)

11.Biomarker Quantification (ELISA)

1.Cell Line Preparation & Treatment

2.Cell Viability, Proliferation & Cytotoxicity

3.Cell Migration, Invasion & Angiogenesis

4.Flow Cytometry & Cell Fate Analysis

5.Oxidative Stress & Drug Response

6.Cell Labeling, Tracking & Differentiation

7.Imaging & Microscopy

8.Organ-on-a-Chip & Advanced In-Vitro Models

9.Advanced Cellular & Molecular Platforms

10.Protein, Antibody & Omics-Related Services

1.IHC, IF & TUNEL assay

2.Fluorescent Staining Techniques

3.Specialized Staining Techniques

  • Structural and Morphological Tissue
  • Fibrosis and Extracellular Matrix
  • Neurodegeneration & Neural Integrity
  • Metabolic Changes & Lipid Accumulation
  • Mineralization and Calcification
  • Vascular Structure and Elastic Fibers
  • Inflammation & Immune Response
  • Vital Function & Cellular Differentiation
  • Microbiological Staining Techniques
  • Microscopic Imaging Platforms

1.Quantitative Analysis & Reporting

2.Tissue Evaluation & Analysis

3.Qualitative & Semi-Quantitative Analysis

4.Scientific & Regulatory Support

1.Isolation, Culture & Identification

2.Biochemical & Phenotypic Characterization

3.Antimicrobial & Antibiotic Evaluation

4.Mechanism of Action & Antimicrobial Resistance

5.Applied & Industrial Microbiology Services

1.Plant Extraction

2.Plant Extract Drying

3.Essential Oil Synthesis

4.Nanoparticle Synthesis

5.Exosome Isolation

Visionofresearch

Regulatory Readiness & CTD Preparation

Our preclinical and regulatory documentation is meticulously structured and authored to meet the exact requirements of the world’s leading health authorities:

  • FDA(U.S. Food and Drug Administration)
  • EMA(European Medicines Agency)
  • GCC(Gulf Cooperation Council)
  • SFDA(Saudi Food and Drug Authority)
  • MOHAP(UAE Ministry of Health and Prevention)

We ensure that every data package, including CTD modules, Safety & Toxicology reports, Pharmacology summaries, and PK/PD studies, is developed in strict compliance with international regulatory standards.

The result is a cohesive, submission-ready regulatory dossier, positioned for smooth review and approval under global and regional fast-track pathways.

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    Veterinary Industry Innovation

    1

    FDA, U.S. Food & Drug Administration

    The FDA mandates a foundation of rigorous, auditable science. Successful submissions are built on robust, reproducible data, full GLP adherence across all studies, and a deep toxicological profile that clearly defines safety thresholds. The agency expects a compelling narrative that integrates strong mechanistic evidence with precise PK/PD rationale, culminating in a comprehensive risk assessment and a defensible integrated summary to support clinical advancement.

    Key Preclinical Requirements:

    • Reproducibility & Traceability:All data must be fully reproducible and documented in detail.
    • GLP Compliance:Strict adherence to Good Laboratory Practice (GLP) in all nonclinical studies.
    • Toxicology Depth:Comprehensive toxicity studies with clear NOAEL/LOAEL determination.
    • Mechanistic Evidence:Data-driven support for proposed mechanisms of action.
    • PK/PD Rationale:Scientific justification for dose selection using pharmacokinetic and pharmacodynamic data.
    • Risk Assessment:Identification and scientific justification of all potential risks.
    • Integrated Summary:A robust, defensible summary narrative for submissions.
    Learn more
    Veterinary Industry Innovation

    2

    EMA, European Medicines Agency

    EMA review places a premium on scientific narrative and translational relevance. Beyond strict CTD compliance, the agency evaluates how well nonclinical data predicts human outcomes. This requires a clear, overarching nonclinical overview, comparative analysis against EU standards, and persuasive evidence, including high-quality imaging, to justify both the mechanism of action and the proposed clinical dose regimen.

    Key Nonclinical Expectations:

    • CTD Structure Compliance:Strict alignment with CTD Modules 2 and 4.
    • Comparative Analysis:Evaluation against EU standards and scientific benchmarks.
    • Nonclinical Overview:Clear, transparent scientific narrative explaining mechanism and development.
    • Human Relevance:Demonstration of translatability from animal to human outcomes.
    • Image-Based Evidence:High-quality histopathology and IHC imaging for mechanistic support.
    • Dose Justification:Thorough, evidence-based dose selection integrating PK/PD and toxicity data.
    Learn more
    Veterinary Industry Innovation

    3

    GCC Regulatory Authorities (GCC-DR, Saudi/GCC Union)

    GCC authorities prioritize a complete, well-organized, and regionally contextualized submission. A seamless dossier requires no gaps in data, standardized presentation for reviewer clarity, and a specialized bridging report to justify the relevance of externally conducted studies. Consistency across all data sets and a tailored nonclinical safety summary are critical for a streamlined review process across member states.

    Key Nonclinical & Regulatory Expectations:

    • Completeness:Fully comprehensive documentation with no gaps.
    • Clarity & Standardization:Consistent formatting of tables, figures, and reports.
    • Bridging Data Requirements:Bridging Report for studies conducted outside GCC.
    • Nonclinical Safety Summary:Region-specific safety summary aligned with GCC frameworks.
    • Consistency:Uniformity across in vitro, in vivo, and PK/PD datasets.
    Learn more
    Veterinary Industry Innovation

    4

    SFDA, Saudi Food & Drug Authority

    The SFDA’s thorough review process demands exceptional depth and precision. Compliance involves exhaustive toxicity studies, strict adherence to local CTD templates, and methodologically sound PK/PD data. A successful submission hinges on statistical rigor, complete data traceability from source to conclusion, and a meticulously documented risk-benefit analysis prepared for detailed regulatory scrutiny.

    Key Nonclinical & Regulatory Expectations:

    • Full Toxicity Panels:Acute, sub-chronic, and chronic toxicity studies with NOAEL/LOAEL.
    • Local Compliance:Adherence to SFDA-specific CTD formatting and templates.
    • PK/PD Data Strength:Precise, validated pharmacokinetic and pharmacodynamic data.
    • Statistical Validity:Robust, transparent statistical methodology for all conclusions.
    • Data Traceability:Full auditability from raw data to final outputs.
    • Risk–Benefit Evaluation:Clear, well-documented assessment for regulatory review.
    Learn more
    Veterinary Industry Innovation

    5

    MOHAP, Ministry of Health & Prevention (UAE)

    MOHAP emphasizes clarity, safety, and international alignment within a CTD framework. The focus is on presenting a straightforward, consistent dossier where safety data is paramount, especially when supported by studies from outside the UAE via a formal bridging report. Ensuring perfect harmony between all report sections is essential for a transparent and efficient review.

    Key Regulatory Expectations:

    • CTD-Based Dossier:Documentation structured according to CTD format.
    • Clarity for Reviewers:Straightforward, transparent data presentation.
    • Safety Assurance:Strong emphasis on nonclinical safety data.
    • Bridging for Imported Data:Bridging Report required for studies outside UAE.
    • Consistency Across Reports:Full alignment between safety, efficacy, and PK documentation.
    Learn more