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GPD Solutions

8025 Lamon Avenue

Skokie, IL 60077 US

Global PharmaDevice Solutions is a GMP Compliance consulting and contract laboratory testing service provider.

In the consulting division, we provide GMP compliance consulting services in areas of consent decree management, investigation/CAPA remediations, software/process/equipment/method validations, quality system architecture, and GMP/ISO auditing.

We also provide analytical testing services for raw materials, intermediates and finished drug and device products, using microbiology and chemistry platforms such as Vertek Microdial ID System, Sterility Isolator, HPLC, GC, Spectrometer, Spectrophotometer, etc. We also provide analytical support in various studies.

For additional information on various services provided by our company, navigate our service web page, complete the form provided, and/or contact us by phone.

Technical Information:

Chemistry Tests:
* Arsenic
* Elemental Analysis
* Gravimetric Analysis
* Acid Digestion
* Organic Volatile Impurities
* Hyaluronic Acid
* Phenol Formaldehyde Resin
* Polystyrene Standards
* Dextrose
* Methyl Cellulose
* Cellulose Acetate
* Adsorbable Organic Halogens
* Alcohols
* Alkalinity
* Aluminum Chloride Assay
* Other monographs and new test methods

Microbiological Tests:
* Sterility
* Microbial Identification
* Bioburden
* Disinfectant Efficacy
* Enrichment
* Temperature Mapping
* Environmental Monitoring
* Bacterial Endotoxin
* Turbidity
* Preservative Challenge Test
* Limulus Amoebacyte Lysate


Validation: Our services in this area include development, review, execution, and approval of master plans, protocols, and summary reports. We provide comprehensive and high quality services in the following areas:

* Computer Software
* Computer Hardware
* Manufacturing Process
* Test Method
* Autoclave
* Refrigerator
* Freezer
* Lab Equipment
* Cold Chain
* Cleanroom
* Aseptic Process
* In-Situ Efficacy Evaluation of Disinfectants
* Incubator.

Auditing: Each experienced GXP Auditor in our organization conducts an average of forty audits each year in both medical device and pharmaceutical industries worldwide. Regulation and Standards covered include:

* ISO 9001:2000
* ISO13485:2003
* Canadian Regulation (CMDR) and

Consent Decree Management: We provide cost effective solutions in handling statement of work under consent decree.

Training: We provide GXP training with certificates of training recognized by industry third-party auditors. Our training programs include:

* GXP Overview
* Auditing Techniques and Guidelines
* CAPA Implementations
* OOS Investigations and Root-Cause Analysis
* Design Control
* Good Laboratory Practices
* Good Clinical Practices
* Good Documentation Practices
* Aseptic processing
* Validation
* ISO Registration Process
* Supplier Quality Implementation and Management.
* Quality Systems Architecture

DISCLAIMER: This Laboratory Profile was provided by the company above.