Pharmaprimes
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Pharmaprimes
Profile
Lab Biography
PharmaPrimes Laboratories is a Contract Research Organization (CRO) based in Amman, Jordan, specializing in advanced pharmaceutical analysis, bioanalysis, biosimilar characterization, and R&D formulation services. With state-of-the-art facilities equipped with LC-MS/MS, HPLC, ICP-MS, and a wide range of analytical technologies, PharmaPrimes supports pharmaceutical companies across the MENA region and internationally in ensuring product quality, safety, and regulatory compliance. Our expert team of scientists and regulatory professionals deliver services aligned with global standards (ICH, USP, EMA, FDA, OECD), covering method development and validation, extractables and leachables, nitrosamine testing, stability studies, and bioequivalence support. Committed to innovation and excellence, PharmaPrimes empowers its partners to accelerate development, achieve regulatory approvals, and expand market access with confidence.
Qualifications
PharmaPrimes Laboratories operates under internationally recognized quality and regulatory standards, ensuring reliability, compliance, and global acceptance of results.
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ISO 9001:2015 – Certified Quality Management System
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ISO/IEC 17025:2025 – Accredited Testing Laboratory
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GLP / GCLP Certification (JFDA) – Certified by the Jordan Food and Drug Administration
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Regulatory Compliance – Services aligned with ICH, EMA, FDA, OECD, USP, and GCC guidelines
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Licenses – Registered with the Jordan Food and Drug Administration (JFDA) as a Contract Research Laboratory
Standards & Methodologies
PharmaPrimes Laboratories conducts all studies and analyses in strict compliance with internationally recognized standards and regulatory guidelines to ensure scientific integrity and global acceptability of results.
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International Guidelines: ICH (Q2, Q3, Q6, Q7, Q9, M7, M13A), OECD, FDA, EMA, WHO, GCC, USP, Ph. Eur., and JP.
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Testing Standards: ISO/IEC 17025 accredited methods, GLP/GCLP-certified procedures (JFDA), and industry-accepted pharmacopeial methods (USP, BP, EP, JP).
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Methodologies:
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Analytical method development, verification, and validation per ICH Q2(R2)
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Extractables and Leachables (E&L) studies per ICH Q3E, USP <1663>/<1664>
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Nitrosamine and NDSRI testing in line with EMA/FDA/SFDA guidelines
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Stability studies under ICH Q1A–Q1F requirements
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Bioanalytical method validation per FDA/EMA guidelines
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Biosimilar characterization and comparability protocols aligned with ICH Q6B and WHO guidance
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Quality Risk Management following ICH Q9 and ISO 31000 principles
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Industry Types Served
Lab Testing Types Offered
- Animal & Veterinary Testing
- Bioassays & Functional Testing
- Biochemistry & Metabolic Analysis
- Biomarkers & Oncology Studies
- Cell & Tissue Culture
- Chromatography & Spectroscopy
- Contaminants
- Adulteration & Purity
- Extractables
- Leachables & Impurity Testing
- Formulation
- Deformulation & R&D
- Immunology & Immunoassays
- Metals & Inorganic Analysis
- Organic Compound Analysis
- Pharmacology & Therapeutic Drug Monitoring (TDM)
- Stability & Shelf-Life Studies