Analytical Services

Pharmaceutical Testing

FDA Registration# 1000151293 | CPT℠ is registered with FDA (FEI # 1000151293) as a Drug Establishment (GMP/GLP/GCP) and a Cosmetic Facility.
DEA Registration# RC0199744 (Analytical Lab) | Schedule I-V license | Remember, Schedules I-II require DEA Form 222 | Registration# RC0171568 (Researcher)
US EPA/NJ DEP Registration# NJD982726648
ISO/IEC 17025:2017 Accreditation # 80071

The testing of Pharmaceutical products is critical to ensuring the identity, purity, quality, and strength of Prescription (Rx) and Over-the-Counter (OTC) drug products sold in the USA.

Pharmaceutical Testing includes all of the following elements:

Testing of raw ingredients used to manufacture drug products.
Testing of drug product batches.
Testing of primary container systems in which drug products are distributed.
Stability Testing of packaged drug products.
Process and Cleaning Validation testing.
Testing in support of New Drug and Abbreviated New Drug Applications for Rx drugs.
Analytical Method Development and Validation.
Verification of compendial analytical testing methods.
Contaminant Testing including Extractables and Leachables (E&Ls).
Environmental Monitoring testing.
Forensic testing of non-conforming materials and product batches.

Each of the above forms of Pharmaceutical Testing plays a critical role in safeguarding the US drug supply. As such, we all have a vested interest in the accurate performance of Pharmaceutical Testing.

Three Reasons Why Clients Put Their Trust in CPT℠ for Pharmaceutical Testing:

1

Our staff of competent, well-seasoned ‘testing professionals’.

2

State-of-the-Art laboratories and testing equipment.

3

CPT℠ understands that the level of GMP compliance that is maintained within each laboratory is just as important as the accuracy of the test results that are generated from that lab.

Obtaining accurate test results is only 50% of our goal; the remaining 50% is maintaining GMP compliance within each of our laboratories thereby assuring acceptance of such results by regulatory inspectors.

How We Help Our Clients

Our clients utilize CPT℠ services in each of the Pharmaceutical Testing areas described above, starting with product development and continuing through post-approval (Rx) or post-launch (OTC) monitoring of product Quality. Why not reach out to us today?

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