Diagnostics
Our Scientific and Regulatory Teams develop customized research programs and conduct individualized Preclinical Studies to ensure that your IND/NDA-enabling Toxicology, Safety Pharmacology, and Laboratory Studies comply with Global Regulations.
Ariba & Mac Limited, through its partnership with Clinical Trial Centres conducts Pre-clinical and Clinical trials for sponsors around the globe in a cost and time effective manner, and proof-of-concept trials—compliant with Global Regulatory frameworks (FDA, EMA, SFDA, GHC, MHRA, DRAP, MENA).
Comprehensive Clinical & Pre-Clinical Capabilities
We perform rigorous Pre-clinical and Clinical investigations designed to assess Safety, Efficacy, and Pharmacological performance before Regulatory submission.
- GLP and non-GLP in-vivo Safety Studies on Rodents and Non-rodents.
- Pharmacology, Toxicology, and IND/NDA enabling programs.
- Bioanalytical Method Development and Validation.
- Clinical Pharmacology and early-phase human studies.
- Collaboration with global CROs and Trial Centers.
- Protocol Design, Data Management, and Statistical Analysis.
- Preparation of Clinical Study Reports and Regulatory Dossiers.
Pre-Clinical Safety Studies
Conduct GLP-compliant Toxicology and Pharmacology Studies to establish Safety and Dosing Profiles.
Clinical Trial Management
Full coordination of Clinical trial phases I–IV, including site selection, monitoring, data capture, and compliance.
Regulatory Compliance
Ensure all studies meet FDA, EMA, SFDA, GHC, MHRA, MENA and DRAP submission standards with Validated Methodologies and Audit Readiness.
Our Approach
We integrate Pre-clinical and Clinical planning under a unified strategy — combining ethical conduct, data transparency, and patient safety as our core principles.
- Integration of Scientific, Ethical, and Regulatory expertise for every protocol.
- Adherence to ICH-GCP, OECD, and GLP standards for all studies.
Protocol Development
Define objectives, species selection, study design, and regulatory requirements aligned to target indications.
Clinical Execution
Conduct trials with data integrity, subject safety, and documentation meeting ICH-GCP and GLP compliance.
Clinical Partnerships & Global Collaboration
We collaborate with global CROs, Hospitals, and Academic Centers to perform compliant and cost-effective Clinical programs.
CRO & Site Collaboration
Partnerships with accredited Research Sites and CROs ensuring consistency, patient safety, and data quality.
Regulatory Strategy
Preparation and submission of IND/IMPD dossiers and support during regulatory inspections.
Ethics & Patient Safety
Commitment to Ethical Research, informed consent, and continuous safety monitoring throughout all Clinical stages.
Frequently asked question
We perform rigorous Pre-clinical and Clinical investigations designed to assess Safety, Efficacy, and Pharmacological performance before Regulatory submission.
Yes. We scope custom Clinical and Pre-clinical Research programs with defined deliverables, timelines and regulatory pathways.
Timelines depend on dosage form and regulatory needs. We provide a project plan with milestones after the initial consultation.
We work with certified partners and maintain cGMP-ready documentation and validation practices.
Use the contact form to outline your needs. We will schedule an advisory call and share a document checklist.