What we offer

Our Services

Comprehensive pharmaceutical research services from bioequivalence to clinical trials.

01 — BIOEQUIVALENCE

Bioequivalence Studies

Our bioequivalence studies are designed to demonstrate therapeutic equivalence between generic and reference pharmaceutical products. We conduct single-dose and steady-state studies across various formulations including tablets, capsules, transdermal patches, and complex generics.

–FDA-inspected facility with proven track record
–Studies conducted per ICH, FDA, EMA, and WHO guidelines
–200+ successfully completed BE studies
–Fast turnaround times with flexible scheduling

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02 — BIOANALYTICAL

Bioanalytical Testing

Our bioanalytical laboratory is equipped with the latest generation LC-MS/MS systems capable of analyzing complex pharmaceutical compounds with exceptional sensitivity and accuracy. We provide method development, validation, and sample analysis for clinical and preclinical studies.

–Multiple LC-MS/MS systems for high throughput
–Sub-picogram detection limits (pg/mL)
–ISO 17025:2017 accredited laboratory
–Validated methods for 500+ pharmaceutical compounds

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03 — CLINICAL

Clinical Trials (Phase I-IV)

PRU offers comprehensive clinical trial services for pharmaceutical companies, from early-phase studies to post-marketing surveillance. Our experienced team manages all aspects of clinical research ensuring compliance with GCP, FDA, and ICH guidelines.

–Dedicated clinical trial unit with 40+ beds
–24/7 medical supervision and emergency care
–Experienced principal investigators and study coordinators
–Access to diverse patient populations

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04 — REGULATORY

Regulatory Consulting

Our regulatory affairs specialists provide strategic consulting services to navigate complex regulatory requirements for pharmaceutical products. We support drug development, registration, and post-approval changes across multiple regulatory jurisdictions.

–Deep expertise in FDA, EMA, and MENA regulatory pathways
–Strategic regulatory planning from development to approval
–Dossier preparation in CTD/eCTD format
–Regulatory intelligence and gap analysis

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05 — MEDICAL

Medical Writing

Our medical writers prepare high-quality regulatory documents and scientific publications that meet international standards. We ensure clarity, accuracy, and compliance with regulatory guidelines while maintaining scientific integrity.

–Experienced medical writers with scientific backgrounds
–Documents prepared per ICH and regulatory guidelines
–Quality control and peer review process
–Fast turnaround with flexible timelines

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