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Services

Bioequivalence Studies

  • Generic & branded BE studies

  • Niche & complex formulations

  • Over 900+ studies conducted

  • Approved by JFDA, SFDA, EMA, GCC, USFDA

Clinical Pharmacology Services​

  • Food-effect studies

  • Drug-drug interaction studies

  • Renal/hepatic impairment studies

Preclinical Research Services

  • In vitro & in vivo pharmacology/toxicology study support

  • Proof-of-concept and translational research

  • Protocol design and regulatory consultation for preclinical-to-clinical transition

Niche & Specialty Services

  • Female-focused clinical trials 

  • Complex BE studies (low solubility, high potency, narrow TI)

  • Medical device trials

Pharmacokinetic & Pharmacodynamic (PK/PD) Services

  • PK/PD modeling & simulation

  • Population PK analysis

  • Exposure-response assessment

  • Biosimilars PK/PD comparability studies

Medical Writing​

  • Protocol writing

  • Clinical study reports (CSRs)

  • Investigator brochures (IBs)

  • Regulatory submission documents

  • Biosimilars comparability & regulatory documentation

Clinical Monitoring & Site Management​

  • Clinical trial monitoring (all phases)

  • Site selection, initiation, and management

  • GCP compliance & quality oversight

  • Risk-based monitoring approaches

Pharmacovigilance & Drug Safety Services​

  • Trial Safety Management

  • Adverse Event Reporting & Processing

  • Safety Database Management 

  • Signal Detection & Risk Management Plans (RMPs)

  • Aggregate Reporting (PSURs, DSURs, PADERs)

  • PV System Audits & Inspection Readiness

  • Training & SOP Development for PV

Bioanalytical Services​

  • Method development & validation

  • Sample analysis using LC-MS/MS (6 systems)

  • 300+ validated methods

  • Equipment:  API by SCIEX , Shimadzu

  • Compliance with ICH M10 guidelines

  • Specialized biologics & biosimilars clinical analysis (immunogenicity, PK/PD, comparability

Statistical Analysis & Data Management​

  • Advanced statistical analysis using WinNonLin, SAS, R

  • Protocol & CRF design

  • Data management & reporting

  • Final study reports for regulatory submission

Clinical Trials (All Phases)

  • Phase I–IV clinical trials

  • First-in-Human (FIH) studies – including SAD (Single Ascending Dose) & MAD (Multiple Ascending Dose)

  • Bioequivalence & bioavailability trials

  • Biosimilars & biologics clinical development programs

  • Specialty trials in: Women’s Health, Cardiology, GI, Respiratory, Hepatology, Gynecology Hematology, Immunology, Oncology, Dermatology, Endocrinology, Neurology Antibiotics, Antivirals, Antifungals, Antiparasitic

Investigational Product Management​

  • Secure storage with restricted access & logs

  • Full inventory tracking & reconciliation

  • Post-study drug return & destruction

  • Cold chain & stability management

  • Special handling for biologics & advanced therapies

Regulatory Affairs & Submission Support​

  • End-to-end regulatory strategy

  • Submission to JFDA, SFDA, EMA, USFDA, GCC, MENA

  • Biosimilars & biologics-specific regulatory pathways

  • Audit readiness & inspection support

  • ICF translation & local regulatory compliance

Pharmacogenomics & Biomarker Services​

  • PGx-guided trial design & patient stratification

  • Biomarker discovery & validation

  • Genetic testing & sequencing support

  • Companion diagnostic development

  • This service is provided in alliance with GENATECHS laboratories for advanced genomic and precision medicine solutions .                                                                             

* To explore our full suite of genomic and clinical services , visit the Genatechs website .

What Sets Us Apart

Years in
the market

Over 26 years in the market.

Healthy
volunteers

Over 10000 healthy volunteers.

 Studies Conducted

Over 1200 Studies Conducted.

Validated
assays

Over 300 validated

assays.

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