OUR FOCUS IS UNCOMPROMISING PRODUCT QUALITY, ABSOLETE CONFIDENTIALITY, DEPENDABLE PROJECT MANAGEMENT, TIMELY DELIVERY AND RESPONSIVE CUSTOMER SERVICE
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OUR SERVICES
As a contract research organization, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes. DRHP’s offerings the most proven solutions to move your product through the development lifecycle as efficiently and cost-effectively as possible include medical device testing; regulatory and quality consulting; and Analytical research services. Driven by our global regulatory expertise and in-depth satisfying knowledge. Customer can also choose the best suitable analytical technique with our Section Guide Information (SGI).
DRHP offers a broad range of analytical testing services including the following listed.
For Medical Devices Samples
ISO 10993-1: Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER)
ISO 10993-13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-14: Identification and quantification of degradation products from ceramics
ISO 10993-15: Identification and quantification of degradation products from metals and alloys
ISO 10993-17: Toxicological Risk Assessment (TRA) of medical devices, packaging materials and CCS
ISO 11979-5: IOLs; Physicochemical tests like Extractables, Leachables, Hydrolytic Stability, Photo Stability and Insoluble Inorganics.
ISO 11981 & ISO 11986: Soft Contact Lenses; Physicochemical tests
21 CFR 177.1500 Chemical Testing of Nylon Resins and Polymers
USP <788> & ISO 19227: Cleaning Validations (TOC, TPH, Residual Chemical Inorganic Matters, Particulate Matter)
EN 1186 Migration Study
ISO 18562-2: Emission of Particulate Matter from Gas Pathways
ISO 18562-3: VOCs from Gas Pathways
ISO 18562-4: Condensate Leachables from Gas Pathways
ASTM D7823-18: Residual Phthalate Testing
Ink Migration and Glassware Delamination Studies.
Toys testing for nitrosamines and phthalates as per EN 14350:2020, EN-71-12, EN-73-14, REACH regulation (EC) No.1907 etc.
BS EN 455-3 and ASTM D5712: Aqueous Extractable Protein Test
ASTM D6499: Antigenic Protein tests .
ASTM D7558: Extractable Chemical Dialkyldithiocarbamate, Thiuram, and Mercaptobenzothiazole Accelerators Test.
IS 16289, EN 14683 & ASTM F2100: Surgical Mask Test
ASTM F2100, EN 149 & NIOSH: N95/FFP Face Mask Test
IS 16546/ISO 16603 PPE Kit Test
EN ISO 374-1: Nitrile Glove Tests
EN 455 Part 1-4: Medical Gloves for single use Test
ASTM D6319 & EN 13795-1: Nitrile Examination Gloves Test
ASTM D3578: Rubber Examination Gloves Test
ANSI/AAMI/ST44, ST60 & ISO 11138-7: Chemical Indicator Color Stability Testing
ASTM D4169: Transport Simulation Testing/ Shipment System Performance Testing
For Pharmaceuticals and other samples
Nitrosamines and NDSRIs Method development and Validation
USP <661> Plastic Packaging Systems and Their Materials of Construction
Unknown peak identification and characterization
Raw material and finished products testing
Genotoxic impurities evaluations (e.g. Nitrosamines, Phthalates, Irganox, Azido impurities etc.)
Ink Migration and Glassware Delamination Studies.
Compendial monograph testing as per the USP, IP, EP, BP, JP, FCC, ACS, etc.
Elemental Impurity analysis as per USP <233>, ICH Q3D, EMA Guideline and/or customer requirements.
USP <661> Plastic Packaging Systems and Their Materials of Construction
Chemical Profiling
Structural elucidation
KSM, Intermediate process testing.
Residual analysis
METHOD DEVELOPMENT
We offer you a comprehensive development method and validation to a wide range of materials. This way, you can apply your validated products and methods to your industry with the best analytical techniques available today.
At DRHP Testing Lab, we have a broad experience in the field and we can even handle the most problematic sample types. In addition, we master a wide range of analytical testing techniques to ensure that your materials have the best results in the shortest possible time and you meet regulatory demands.
Our team has expertise in consumer product testing and our analytical techniques facilitate the development of accurate methods. In fact, we have customized testing plans for specific products in which we analyse multiple factors and their impact on the results.
At the end of the method development process, you will receive a comprehensive report that includes the evaluations, results and statistical report of the applied test – And if you have any questions you can consult with our staff. They are able to explain the applied processes for your comfort and safety!
Robust and stability-indicating methods are significant drivers to ensure product quality and ensure faster regulatory approval.
Our method development strategy involves the use of proper scientific approaches and scientific literature reviews which lead to the appropriate selection of analytical techniques for the targeted product.
DRHP is capable of developing phase-appropriate analytical methods from key starting materials to finished products (Drug Substances and Drug Products).
We specialize in Method Development of the following:
Stability-indicating related substances by HPLC (including UV transparent compounds)
Stability-indicating assay methods by HPLC (including UV transparent compounds)
Purity by HPLC
Residual solvents by GC/GCHS
Enantiomeric purity by HPLC (Global leader in this area)
Genotoxic impurity quantification at ppm and ppb level (LC-MS/MS, LC-QTOF/MS, GC-MS/MS, GC-QTOF/MS)
Screening and development of methods for elemental impurities by ICPMS, as per USP general chapter <232>, <233>, ICH Q3D
Non-carry over studies at ppm and ppb level by LC-MS/MS, GC-MS/MS with QTOF.
Residue/cleaning analysis.
Quantification of ions by Ion Chromatography
In-process control methods for intermediates
Extractable and Leachable studies.
By following our “First Time Right” concept, we support all of our customers by developing appropriate analytical methods, without compromising on quality, and completing projects within agreed timelines.
A dedicated team can be assigned, for a particular project, based on customer requirements.
METHOD VALIDATION
We are able to provide a testing protocol customized to your specific requirements and quality needs. Our testing protocols follow regulatory guidelines and guarantee you validated results for your materials.
Similar to our method development service, in the validation process, we will provide you with a validation report with statistical data – And if you have any questions, you can discuss with the validation team your particular requirements!
Method validation is one of the most crucial components in any regulatory submission.
Our validation protocols and reports are based on globally accepted guidelines such as ICH/FDA/USP/ANVISA requirements and cover various parameters.
We are capable of validating methods to support DMF/ANDA filings.
We perform method validation as per ICH Q2 requirements, meeting 21 CFR Part 11 regulatory requirements for electronic review and electronic signatures.
We make sure that you can always count on the quality of your results. In fact, we provide you with detailed reports of the results of your validation and method development with the corresponding explanations.
You will understand how the procedure was performed and you will be aware of each of the phases of the evaluation of your materials and products. Not only do we have great scientists who are experts in their field, but also human beings who care about your projects.
CHEMICAL CHARACTERIZATION & E&L
With over 100 years of combined experience, DRHP Testing Solutions provides reliable chemical characterization and analytical chemistry solutions to clients. We offer a comprehensive range of testing services aimed at ensuring product safety, quality, and consistency at every stage of development. Our trusted industry processes effectively define device components and enable precise assessments of reproducibility in manufacturing and processing, ensuring your products meet the highest standards of performance and compliance. Over the past year, we have successfully conducted numerous chemical characterization studies worldwide, with many of our reports receiving USFDA approval in a single review.
Chemical characterization is the process of obtaining chemical information about a material by gathering or generating information. It involves identifying the material and its chemical constituents, and quantifying them. Chemical characterization can be used to evaluate the safety and effectiveness of a device and its components. It can also help to understand the relationship between the structure and properties of nanofibrous materials.
Chemical characterization is a crucial part of the biological evaluation of medical devices. The extent of characterization depends on the type of material, the end use of the device, and the function of the material within the device. The degree of characterization also depends on the nature and duration of body contact with the medical device.
Some chemical characterization methods include: LC-QTOF/MS. GC-QTOF/MS, LC-MS/MS, GC-MS/MS, ICP-MS, XRD, IC, NMR, Gel permeation chromatography, and FTIR.
RISK ASSESSMENT
A risk assessment is a process that identifies potential hazards and risk factors that could cause harm, and then analyzes and evaluates the risk associated with the hazard. The goal of a risk assessment is to eliminate the hazard or minimize the risk by adding control measures.
The risk assessment process should be reviewed and updated regularly. The five steps in the risk assessment process are:
Identify the hazards
Determine who might be harmed and how
Evaluate the risks and take precautions
Record your findings
Review your assessment and update if necessary
SARAH, DEREK and OECD evaluations will be performed
A chemical risk assessment follows these 4 steps: hazard characterization, exposure assessment, dose-response modeling, and risk characterization.
Our approved EU & USA (DABT) Toxicologists will give the complete Toxicological Risk Assessment (TRA) report for any regulatory submissions .
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