Testing Types
Method Development

Method Development

Scientifically designed analytical methods developed to support product characterization, quality evaluation, regulatory submissions, and lifecycle testing requirements.

Terms and Conditions

I. Confidentiality:

PLS Analytical ("PLSA") maintains strict confidentiality with its clients.

Formal Confidentiality agreements may be initiated by the client or by PLS Analytical.

II. Financial Information

Payment in advance is required for clients whose credit has not been established with PLSA.
Payment terms are “NET 15 days from receipt of the results”. Buyer agrees to pay all costs, including, but not limited to attorney and accounting fees and other expenses of collection resulting from any default by buyer in any of the terms of this contract.
Purchase orders or valid credit card information are REQUIRED. Orders submitted without this information may cause delays in testing.
For third party billing a signed purchase order must be received from the party paying for the service.
A surcharge of 50% or greater will be added for EXPRESS service. Express is subject to prior approval and availability.
Pricing is designed for single samples. Project discounts may be available. Quotations will be provided free of charge.
A minimum billing of $25.00 will be charged on all samples including those samples cancelled at the customer's request.
Clients that request Raw Data will have a copy sent to them electronically (at no charge) along with their report. There may be a surcharge for copies of the raw data and report when requested after initial sending is completed.
Additional charges may be assessed (e.g. hazardous samples, composite fee).
Shipping costs will be charged to clients that would like containers, coolers or ice packs returned.
Liability of PLSA is limited to an amount no greater than the amount invoiced.

III. Sample Submission:

Fill out the Sample Submission Form COMPLETELY, including product name, lot number, test, methods, and the amount of samples sent. Incomplete information may cause a delay in providing services.
All results will be reported by the method supplied and/or identified. If a limit is not supplied, we will default to associated compendia limits, or “Report Results” when compendial limits are not available.
All samples should be labelled with company name, product name and lot number. Samples received without a lot number will be sent back to the client for proper labeling. Hazardous Substances must be appropriately labeled for the protection of office and laboratory personnel.
- Shipping carton exterior must be labeled as to the hazard enclosed; caustic, cytotoxic, antineoplastic, explosive, corrosive, toxic, or carcinogenic, etc.
- Safety Data Sheet (SDS) must be provided for all Hazardous samples.
- Additional charges may be applied.
- Please place Sample Submission Form, SDS and any other correspondence submitted, in an envelope and place at the top of the box or affixed to the outside of the box. Failure to use the PLSA Submission Form for Analytical Services may delay results.

IV. Retention and Disposal:

Samples are retained for a period of 30 days after completion of analysis.
Special PRIOR arrangements must be made to return or retain samples under other conditions.
Unless alternate arrangements have been made, raw data will be retained for 6 years after final report date.

IMPORTANT

Turnaround Times:
- In calculating turnaround times, pending all appropriate documentation is in order; if the sample is received before 10 am then the day the sample is received is Day 1 otherwise it will be on the next business day.
- Standard TAT is 10 Business days.
- Express Service is subject to prior approval, availability and surcharges.
- For International orders, please allow sufficient time for samples to clear customs.
Please pack samples appropriately to prevent breakage.
Because transportation of materials to our facilities can have significant impact on the moisture content of client sample materials, PLS Analytical will not accept client-provided Loss on Drying/Moisture content results. When required for testing, the Loss on Drying/Moisture Content will be performed at PLS Analytical and will be billed to clients at a flat rate. Please contact our Customer Service Team for current associated costs.
If growth is obtained during microbial enrichment testing, a gram stain will be performed and billed to the client. Please contact our Customer Service Team for current associated costs.
For Questions regarding the above information please contact our Client Services Department at 732-698-5050.

I confirm that I have read and accept the terms and conditions.

Sample Submission Form

Submitter Information

Date

Company Name / Address

Contact Name

Billing

Send Invoice To

If differentSame as Report

Name and email for invoicing

Order References

PO Number*

Quote Number*

Turn Around Time

StandardRush

Express, needed byInclude Raw Data

Controlled substance

Yes No

Microbiology sample suitability

YesNo

Analytical sample: method verification required

YesNo

Special Instructions

Fill The Sample Columns

SAMPLE NAME	LOT # (ONE LOT PER LINE)	METHOD (MUST BE PROVIDED)	TEST REQUESTED (MUST BE PROVIDED)	SPECIFICATION (MUST BE PROVIDED)	QUANTITY

Required for Testing to Begin Customer Initials and Date

Overview

What is an Analytical Method?

An analytical method is a scientifically developed procedure used to evaluate critical quality attributes such as identity, potency, purity, assay, impurities, and degradation products. At PLS Analytical, robust analytical methods form the foundation for generating reliable data that supports product development, quality control, and regulatory decision-making.

What is Analytical Method Development?

PLS Analytical develops analytical methods tailored to specific products, formulations, and testing objectives. Method development involves selecting appropriate analytical techniques, optimizing test conditions, and establishing procedures that consistently deliver accurate, reproducible results. These methods support formulation development, stability studies, impurity profiling, release testing, and subsequent method validation activities.

Why it Matters

Reliable analytical methods are essential for generating accurate data throughout the pharmaceutical product lifecycle. Well-developed methods help manufacturers monitor critical quality attributes, identify impurities, support stability programs, and reduce the risk of inconsistent results, investigation findings, or regulatory delays.

PLS Analytical develops scientifically robust, regulatory-aligned analytical methods that support validation, technology transfer, quality systems, and submissions in accordance with ICH Q14, ICH Q2(R2), and global regulatory expectations.

Testing Services

Develop analytical procedures aligned to product and regulatory requirements

PLS Analytical develops and optimizes analytical methods to support pharmaceutical development, quality control programs, stability studies, and regulatory submissions across a wide range of product types and dosage forms.

1. Method Feasibility & Development

Method feasibility and development establish analytical procedures capable of accurately measuring target compounds and critical quality attributes. Scientifically robust data supports new product development, early-phase formulation studies, non-compendial methods, and product-specific analytical strategies.

2. Method Optimization & Troubleshooting

Method optimization and troubleshooting evaluate existing analytical procedures to improve performance, reliability, and robustness. Scientifically robust data supports process changes, reformulations, OOS investigations, method refinement, and operational efficiency.

3. Stability Indicating Method Development

Stability indicating method development establishes analytical procedures for monitoring product stability, degradation pathways, and impurity profiles throughout the product lifecycle. Scientifically robust data supports stability programs, impurity profiling, shelf-life studies, and regulatory submissions.

Advantages

Built for reliable, regulatory-ready analytical performance

Analytical method development provides the scientific foundation required for accurate testing, effective quality control, and successful regulatory submissions.

Fit-for-Purpose Method Design

Methods are developed around the specific characteristics of the product testing, ensuring that analytical procedures remain suitable for their intended application.

Reliable and Reproducible Results

Systematic development and optimization help establish methods capable of delivering consistent, accurate, and reproducible data across routine laboratory operations and quality programs.

Reduced Development and Validation Risk

Early identification of analytical challenges helps minimize delays during validation, technology transfer, stability studies, and commercial implementation, improving overall development efficiency.

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