Pharmaceutical Division

IAL Pharmaceutical Division

IAL provides analytical services for pharmaceutical, cosmetic, specialty chemical, and medical device manufacturers. Offering a broad array of testing services, we provide the development support needed to meet regulatory guidelines throughout your product's life cycle. Our services are provided under the cGMPs required by the FDA, and we routinely support audits by the FDA and by our clients. 

IAL offers a comprehensive range of pharmaceutical testing, and our scientists will work side-by-side with you to achieve project success. Our services include:

  • Elemental Impurities Q3D, USP <232> and <233> (Read About Upcoming Changes)
  • Quality Control Release Testing
  • Method Development and Validation
  • Method Transfer 
  • Method Verification
  • Compendial Testing includes USP/NF, EP, BP, JP, FCC and AOAC Methodologies
  • Stability Testing
  • Sample Stability and Retain Sample Storage
  • API or Select Raw Materials Testing 
  • Residual Solvents
  • Cleaning Validation
  • Cosmetic Product Testing
  • Dissolution
  • Nutraceuticals
  • Trace Metal Analysis 

We welcome your questions and invite you to contact us to discuss your project needs.

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  • Development

    Method Development

    Procedure Development, Optimization, and Validation

    IAL offers comprehensive method development, optimization and method validation services through a staff of knowledgeable and experienced pharmaceutical senior scientists.

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  • Impurities by ICP/MS

    Elemental Impurities by ICP/MS

    ICH Q3D and USP <232> and <233>

    IAL helps implement USP guidelines replacing wet chemical “heavy metals” limit tests with more reliable, faster and lower-cost ICP/MS techniques.

    Read more

  • Stability

    Stability Services

    Stability Testing and Services

    Evaluation of stability is a critical aspect of drug substance and drug product testing.

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  • Materials

    Raw Materials, Excipients and API

    Compendial Testing

    Ensuring that your raw materials meet specifications is essential to prevent product failure.

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  • Storage

    Reserve Sample Storage

    Controlled Chambers for Retain Samples and Customer Complaint Testing

    FDA Title 21 Section 211.170 indicates that reserve samples of active ingredients as well as drug products that are representative of entire lots shall be retained.

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  • Personal Care

    Personal Care Product Testing

    Cosmetics and Other Personal Care Products

    IAL is an independent contract testing and research laboratory. Our services include providing formulators and manufacturers of cosmetics and other personal care products testing so that they can meet regulatory and safety requirements.

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  • Cleaning

    Cleaning Validation

    Guidance on Plan Development and Execution

    IAL is a cGMP compliant facility available for developing, validating and performing analytical procedures used in equipment cleaning validation.

    Read more

Contact Us

Office hours

Mon-Fri 8am - 5:30pm
Sat-Sun Closed
Holiday Schedule

Location

Integrated Analytical Laboratories, LLC
273 Franklin Road
Randolph, NJ 07869

Sample pick-up/drop

Mon-Fri 8am - 6:30pm
Sat-Sun Closed

Contact

Phone 973-361-4252
Fax 973-989-5288