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AMRI
Aizant Drug Research Solutions Pvt. Ltd.
Anacipher
Boston Analytical
Crenza Pharma
DPT Laboratories, Ltd
Doctor's Analytical Laboratories
GRAM Laboratory Inc
Megsan Labs Private Limited
Pace Analytical Services, LLC
Primera Analytical Solutions Corp
Quantex Laboratories
Sartorius Stedim Biotech
Vitas Analytical Services
West pharma services
mKnal Global Solutions
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UNITED STATES
A partner for the pharma and biotech industries to improve patient outcomes & quality of life
- Service Details
AMRI offers extractables and leachables (E&L) testing services to assist in the evaluation of the manufacturing process, including single use systems (SUS), final container/closure, drug delivery devices & overall packaging configuration of your product.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
West offers extractables/leachables analysis for packaging and delivery systems for all pharmaceutical and biological products.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Our scientists conduct extractables and leachables studies in accordance with Good Manufacturing Practices (GMPs) ,PQRI recommendations, United States Pharmacopeia (USP) requirements.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Our extractables and leachables analytical services include: Modify and validate controlled extractable methods for testing and profiling of leachables and Develop HPLC, GC, and MS methods for controlled extractables from pharmaceutical containers, closures and devices.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Extractable and Leachables (both organic and inorganic) study in drug product. It offers development and validation of analytical methods, study stability sample for establishment of leachables maximum level, and qualification of extractable and leachables.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Boston Analytical's staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
DPT’s provides reliable and accurate analytical testing services for Extractable & Leachables.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Sartorius offers unique expertise in the field of extractables & leachables, such as extractables evaluation, extractables & safety assessments, E&L long-term/storage studies for different container materials, leachables screening, etc.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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- Service Details
DALPL's current services at the pharma division include extractable & leachables as per FDA guidelines & PQRI suggestions, genotoxic impurity [nitrosamine impurities] quantification studies, carryover impurity studies, elemental impurities by ICP MS, etc.
- Directory Listing
Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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