A unique mix of innovation and agility for impeccable results.

BRAND VIDEO

Method Validation based on current USP and ICH guidelines.

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METHOD VALIDATION

Testing of raw materials, finished products, in-process, and stability samples.

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LAB TESTING

Onsite Laboratory Training including HPLC.

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ONSITE LAB TRAINING

US FDA cGMP consulting, training and audit.

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cGMP CONSULTING

A unique mix of innovation and agility for impeccable results.

Chroma Research Labs operates as a state of the art analytical lab, in Long Island, NY. This facility is utilizing Inductively Coupled Plasma/Mass Spectrometer, High Performance Liquid Chromatograph, UV/Vis Spectrophotometer, Gas Chromatograph, Fourier Transform Infrared Spectrophotometer, Dissolution apparatus, precision balances, pH meters, Karl Fischer titrator, and other necessary accessories for the development and validation of test procedures that can be used by pharmaceutical drug manufacturers. Heavy metals testing and minerals testing are carried out using Inductively Coupled Plasma/Mass Spectrometer (ICP-MS). It provides detection and quantitation of of elements which range from ppm to ppt concentration levels. Identification, Assay, Content Uniformity and impurity tests are carried out using High Performance Liquid Chromatography, Gas Chromatography, and UV/Vis and FTIR Spectrophotometry.

With the experience and expertise of our lab staff, we provide an excellent platform to deliver the highest level of quality assurance for our clientele. With an expansive array of advanced technology we are able to provide the pharmaceutical industry with accurate and reliable testing results in a timely manner. Our testing can also assist in the quality assurance of key operational areas: Regulatory compliance, Policies and Procedures, Documents and Records, Facility and Equipment validation and Training.

With Chroma Research Labs, you’ll get a partner who understands the unique requirements of your business and industry to provide the technical expertise, innovation and world-class facilities for precision that enable you to bring products to market faster and meet all quality, health and safety standards.

Chroma Research Labs provide quality and innovative services for:

General Lab Testing | HPLC Analysis | Heavy Metals Testing | Drug Dissolution Profile | Accelerated Stability Testing | Impurity Testing | Method Development | Method Verification Method Validation | Method Transfer | Computer Validation | Equipment Validation | Laboratory Training | HPLC Training | GMP Audit

About Us

Serving the pharmaceutical industry with innovative leadership.

To serve the pharmaceutical industry by delivering high quality service at affordable price
  • Adherence to GLP guidelines of FDA.
  • Utilization of modern analytical technology along with highly skilled professionals.
  • Our customer service team is experienced and well trained in our specific field.
  • Observation of Good Laboratory Practices throughout the testing processes.
  • Quality of our work and the satisfaction of our clients.
  • Quality Service and lower pricing.
  • Rapid turnaround time.
  • Well versed in the FDA and regulatory guidelines.

Chroma Research Labs is incorporated in NY State as an S Corporation.

Mathew ChamakkalaSR. DIRECTOR QUALITY

Mathew Chamakkala is a Pharmaceutical professional for the last 33 years having worked for Contract Pharmacal, Hitech Pharmacal, Forest labs and TwinLabs. He is the founder of Chroma Research Labs, a firm focused on HPLC Method Development & Validations and other lab-related services. Mathew is a Pharma consultant for MM Stan Inc., and previously was Director of Analytical R&D at Contract Pharmacal which develops, manufactures and packages premium pharmaceuticals, over-the-counter drugs and dietary supplements. Prior to that, he served as Director of Quality Control at CPC. He started his career at Duramed Pharmaceuticals as an analytical Chemist. He manages the Linkedin Group "Analytical Method Validation".

Services

Precise analytical processes for superior operational efficiency.

Chroma Research Labs is assisting Pharmaceutical, Nutraceutical and Cosmetic companies and chemists in developing and validating chromatographic test procedures, conducting lab testing as well as laboratory training. It also conducts GMP audits, Process validation, Cleaning Validation, Equipment validation and Computer validation. Chroma Research Labs operates from one facility located in Long Island, NY. Our knowledgeable lab personnel, along with the quality of their work, will drive the repeat business that we mainly rely upon.

Chroma Research Labs is able to provide cost effective service to our clients due to operating efficiencies from modern high speed and high precision laboratory equipment in conjunction with highly experienced chemists.

Professional services of Chroma Research Labs include:

  • Development and validation of HPLC (High Performance Liquid Chromatography) procedures for the analysis of OTC (Over The Counter) and prescription drugs as per USP (United States Pharmacopeia), FDA (Food and Drug Administration), EMA (European Medicines Agency) and ICH (International Conference on Harmonization) guidelines
  • Analytical release testing of Pharmaceutical/Nutraceutical raw materials and finished products as per USP, EP, BP, AOAC and in house validated procedures.
  • Accelerated stability program to support shelf life determination.
  • Dissolution testing and sustained release testing of pharmaceutical products.
  • Dissolurion comparison study (F1 and F2) of generic drug product versus brand
  • Heavy metals and minerals testing for Dietary supplements and drug products.
  • GMP training, GMP auditing, Process validation, Computer System Validation, and Cleaning validation
  • Onsite laboratory training

Chroma Research Labs' competitive edge is superior service and low pricing. To do that we maintain our position as the low cost provider by painstakingly ensuring that costs are kept low through operating efficiencies. We are able to achieve operating efficiency by employing well qualified individuals and by utilizing high speed and precision equipment that are available in the current market.

METHOD VALIDATION

Top quality validation services with unmatched accuracy.

Method Validation is based on current USP and ICH guidelines. Accuracy, Precision, Linearity, Ruggedness, Robustness, Limit of Detection, Limit of Quantitation and Specificity will be studied as well as the filter study and solution stability studies based on client's requirements.

Based on Client's request, Chroma will set up a meeting and discuss the needs and requirements that Chroma needs to fulfil on the client's behalf. The client may conduct an audit of the facility before or after this initial meeting. Pricing and a time frame for completion of the project will be discussed and agreed during the meeting. Once the project details are delivered by the client, Chroma will write the protocol and send to the client for approval. Once the protocol is approved, the project will be started. Upon the execution of the protocol, the report will be delivered within a mutually agreed upon time frame. Chroma Research Labs takes the full responsibility of the projects we finish. Any delay in the process will be communicated with the client.

LAB TESTING

High speed and High precision testing by experienced chemists.

Chroma Research Labs performs Identification, Assay, and Impurity testing on raw materials, finished products and in-process samples. We also conduct uniformity of dosage units and dissolution testing on drug products and dietary supplements as per USP guidelines. Finished products lab testing such as Identification, Assay, Impurities, Content uniformity and dissolution will be conducted according to current requirements. Other tests include Stability Study at accelerated temperature and humidity as per ICH guidelines, Degradation Study, Clinical Trial analytical support, Compendial Testing, Titrimetry, Karl Fischer Water Determination, Minerals assays, ​ and California Prop 65 Heavy metals testing for raw materials and finished products​. Out of Specification and Out of Trend issues will be addressed properly.

ONSITE LAB TRAINING

Onsite trainings for a comprehensive lab experience.

Chroma Research Labs offers Laboratory Training including HPLC. This 36 hours course will give the students an overall lab experience. Almost half the time, they will be learning High Pressure Liquid Chromatography (HPLC) technique which is one of the most valuable analytical tools in the chemical/pharmaceutical industry. They will be working with Hitachi HPLC system with a Diode array detector using EZChrom software. They will also learn Uv/Vis spectrophotometry and dissolution of drug products. The students will be provided with written instructions, notebooks, safety goggles, gloves, lab coats, and scientific calculators. Basic Lab training, Method Validation training, HPLC training and Dissolution training are conducted routinely for those who would like to gain lab experience to find a Chemistry related job in the Pharmaceutical, Dietary supplement, Cosmetic and Chemical Industries.

Lab Training details

  1. Laboratory safety - Based on OSHA guidelines
  2. Good Laboratory Practices-Based on GLP USFDA Guidelines
  3. Daily Calibration of analytical balance
  4. Weighing of a sample using analytical balance
  5. Daily calibration of pH Meter
  6. Taking pH Measurement of samples
  7. Preparation of volumetric solution - 0.5N Hydrochloric acid USP
  8. Standardization of volumetric solution - 0.5N Hydrochloric acid USP
  9. Assay of Vitamin C using Iodometric titration (USP)
  10. Specific gravity measurement of a liquid using Pycnometer
  11. Pipetting
  12. Water determination using Karl Fischer titrator
  13. Dissolution of a drug product using Dissolution apparatus and a UV spectrophotometer
  14. Overview of Chromatography techniques
  15. Overview of HPLC columns
  16. Mobile phase preparation
  17. Assay of a finished product using HPLC
  18. Resume review
  19. Interview Preparation

cGMP CONSULTING

Knowledgeable
and focused
consulting services.

We offer US FDA c GMP consultation, validation and regulatory affairs solutions for companies seeking to obtain a competitive advantage and compliance to various areas of GMP. Our Pharmaceutical consulting team includes international experts and GMP consultants who have previously held leadership roles within the industry. Our Medical Device consultants have extensive knowledge of Medical Device regulatory requirements, including Medical Device classifications. Our approach to current Good Manufacturing Practice (cGMP) is very concise and provides quality documents to your staff and then makes sure that it is followed and the results documented. We implement GLP and GMP Quality Management Systems, perform GMP audits and offer practical recommendations for closing the identified gaps. Our Validation consulting services include C&Q for Facility Utility, Equipment, Packaging Lines, Cleaning Validation and Computer Systems Validation as well as Pharmaceutical and Medical Device Process Validation to PIC/S, GHTF, EMA, FDA and TGA regulations.

CONTACT US

Using our
agility to
help serve
you better.

Chroma Research Labs, Inc.
25 Health Sciences Drive
Suite 106, Stony Brook,
NY 11790
Phone: 631 721 0010
Fax: 631 444 8825
E-mail: mathew@chromaresearchlabs.com
info@chromaresearchlabs.com

FDA Registered cGMP/GLP Facility

FDA Registration No. 3012459224
DEA Registration No. RC0502496
NYS DOH Controlled Substance License No. 0800341

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