FDA Registered ● 8 Day Standard Turnaround Time ● ICP-MS Trace Metals Analysis ● Nasal Spray In Vitro Equivalency Studies, HAM Studies, Characterization and Stability Studies ● Quality Driven Call Us Today! +1 (732) 698-5050|info@plsanalytical.com

Services

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Services2019-03-31T15:42:20-04:00

Industry Served

  • Pharmaceutical

  • API

  • Raw Materials

  • Dietary Supplement/OTC

  • Consumer Goods

Analytical Services

At PLS Analytical, raw material, in-process material and product quality as well as cGMP compliance are of the highest importance when manufacturing nutritional and dietary supplement products for our customers. We are committed to formulate and manufacture the safest and most effective Nutraceutical & dietary supplements for our customers and partners by:

  • Conducting Formulation Studies, Stabilities Studies and Product Development Testing in our in-house and on-site Product Development Lab.
  • Testing the quality of our raw materials and products in our on-site, state-of-the-art laboratories. Our experienced scientists test the identity, purity, strength, composition, and limit of contaminants in raw materials and products QC labs.
  • PLS Analytical’s laboratories house some of the most advanced equipment for product development and QC testing.

Following is the glimpse of the lab equipments in Our QC Lab:

  • Oral Solid QC Testing Instruments

  • Oral Liquid QC Testing Instruments

  • Oral Spray QC Testing Instruments

  • Gas Chromatography with Head Space

  • HPLC Instruments with UV/ELSD/RI detectors

  • ICP-MS

  • UV – VIS Spectrophotometers

  • FTIR Spectrophotometers

  • Stability Chambers

  • Polarimeter – Purity Identification for Amino Acids

Analytical Services PLS Analytical

Submit a quote request or call (732) 698-5048 today for a consultation with our management team.

FDA_Approved_PLS Analytical

ANDA Development

  • Active

  • Inactive Pharmaceutical Ingredient & Excipient Testing

  • Cleaning Validations

  • Product Development

  • Sourcing of Active Pharmaceutical Ingredients & Excipients

  • Product marketability Evolution

  • Pilot Batch Manufacturing and Stability Evaluation Bioequivalence Studies

  • Performance Monitoring Report

  • Compiling and Electronic Submission of ANDA (e-CTD format) Pre-marketing process validation

Elemental Impurities

PLS Analytical can analyze for elemental impurities using a Shimadzu ICP-MS Model 2030:

  • Finished Drug Products
  • Raw Materials

  • Nutritional Supplements

  • Topical Products

  • California Proposition 65
  • USP <232> <233>

Nasal_spary_PLS Analytical

Nasal InVitro Bioequivalence Testing

PLS Analytical has the availability to perform InVitro Bioequivalency Studies:

  • Single Actuation Content (SAC) Through
  • Container
  • Life
  • Droplet Size
  • Drug Small Particles
  • Plume Geometry
  • Priming and Repriming

Microbiology

  • Extractable and Leachable Evaluations
  • Method Development and Validation
  • Method Development & Validation for Leachable Studies

Full Time Equivalent (FTE) Program

  • Achieve Project Goals

  • Work Flexibility
  • Manage & Control Costs
  • Increased Productivity

  • Short Term or Long Term

  • cGMP Trained Personnel

  • Program can be Either Insourcing or Outsourcing

About-Us PLS Analytical

Stability Storage and Testing

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.

Method Development, Validation and Transfer

Analytical methods development and validation play important roles in the discovery, development and Manufacture of pharmaceuticals. Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compounded dosage form which allow simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation. The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. In summary, analytical method development and validation allows to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed.

Discover The Future

We are a multi-disciplinary laboratory committed to focussed and efficient drug discovery

Contact Us