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Bioanalytical Method Development and Validation

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Quantitation Of Metabolites and Drugs In Biological Matrices

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LC/MS And LC/MS/MS GC/MS And GC/MS/MS Liquid Chromatography

Automated Solid Phase And Liquid- Liquid Extraction

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ELISA, Electrophoresis, Bioassays Affinity Chromatography Protein Assays Peptide Sequencing

Chemical Analysis Services

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    Finished pharmaceutical products:

    • Method development activities to support de-formulation studies and determination of active/excipient ratios

    • Method Validation Phase I, II, III

    • Release Testing

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      Raw material and Excipients testing:

      • Proof of structure

      • Identification and quantitation

      • Establishment of purity as well as release

      • Specification development for excipient- masking transformations Packaging components Physico- chemical testing Moisture permeability Container-closure integrity evaluations

      • Extractable /leachable determinations HPLC, IC, LC/MS, GC, GC/MS

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    Chromatographic Purity And Stability Indicating Assays

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      Solid Oral - Assay, Impurities, Content Uniformity

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      Liquid Oral - Assay, Impurities, Dose Uniformity

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      Cleaning Verification Methods.

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      Impurity Identification

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      High Resolution Mass Spectrometry Liquid and Gas Chromatography

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      HPLC , GC , Chiral HPLC And Chiral GC, and Capillary Electrophoresis

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      Ion Chromatography

Microbiology Services

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    Microbiology Testing for: Pharmaceuticals,

Cosmetics, and Food Industries

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    Microbial Identification, Microbial Limits

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      Water Testing, Air Sampling

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      Bioburden Analysis

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      Kinetic LAL

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      Bacterial Endotoxin Test

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      Minimum Lethal Concentration

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      USP and ASTM Testing

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      Aerobic and Anaerobic Plate Count

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      Fungal Plate Count

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      Mold Testing

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      Contamination Determination

Bioanalytical Development

Regulatory & Audit Services

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    Preparation of IND, NDA, ANAD and CMC , Setting Strategies With FDA for Successful Submissions

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      Interacting Directly With FDA

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      Consulting for Regulatory Submission

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      System Audit (QA), Review, & Training

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      GMP/GLP Site Audit, Audit Reports

Computer Validation Services

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    Project Planning

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      Risk Assessment and Analysis

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      Developing User Requirement Specification (URS) and Functional Requirement Specification (FRS)

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      Validation Protocols

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      Validation Reports

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      Traceability Matrix, & Sop Development

Instrument Qualification & Repair

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    HPLC Installation, Operational And Performance Qualifications (IQ/OQ/PQ)

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      HPLC Preventative Maintenance And Repair Services Facility Design and Validation

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    Facility Validation and Designing:

    • HVAC System Validation

    • Water System Validation

    • Security System Validation CALL (800) 421-5284

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