Stability & Shelf-Life Determination
Product Description
Selvita
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PL -
2020On CPHI since
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1Certificates
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1000 - 4999Employees
Company types
Primary activities
Categories
Selvita
-
PL
-
2020On CPHI since
-
1Certificates
-
1000 - 4999Employees
Company types
Primary activities
More Products from Selvita (4)
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Product Analytical Methods
At Selvita, we understand that robust and reliable analytical methods are critical to the success of drug development. Our approach to analytical method development, optimization, qualification, and validation is rooted in our extensive expertise and commitment to excellence. Here’s how we ensure that our ... -
Product Bioanalysis of Biologics & Biosimilars
At Selvita, we offer comprehensive bioanalytical services for a wide range of biological drugs, including innovative proteins, biosimilars, therapeutic peptides and enzymes, biomarkers, monoclonal antibodies, hormones, nucleic acids, and other large molecules. As a GLP-certified and GCP-compliant multinati... -
Product CMC analytical support
Leveraging state-of-the-art technology and rigorous scientific methodologies, we provide a full spectrum of CMC analytical support, including:
· Method Development and Validation
· &nb... -
Product Formulation development, GMP manufacturing, and clinical supply of solid oral doses
At Selvita, we specialize in comprehensive formulation development services, offering a range of dosage forms, advanced key technologies, and solutions for challenging formulations. Our state-of-the-art laboratory is equipped to handle both GMP and non-GMP projects, ensuring high-quality and efficient outc...
Frequently Viewed Together
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Product Protein Aggregation Analysis and Characterization
Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, rel...
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Product Stability tests according to ICH
Neotron Pharma provides Stability tests according to ICH standards (zones I, II, IV). We can carry out stability studies in their entirety (storage + analysis) or provide only storage service. The conditions we can offer are listed below:
- 40°C ± 2°C , 75% ± 5% U.R.
- 30°C ± 2°C&n...
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Product Biotherapeutics
To accelerate the development and marketing of your Biotherapeutics, Quality Assistance offers a complete analytical package to meet the EMA and FDA requirements, all on one site.
Whether it is to extend your analytical capacities or to outsource parts or all of your analytical needs, ...
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Product Analytical Chemistry & Microbiology Services
Our expert team provides full analytical, microbiology and stability services to ensure that your raw materials, bulk product and finished products are qualified, analyzed and released to cGMP standards.
Our services include:
Analytical
• Raw material and drug product...
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Product Stability Studies
Solvias offers the complete range of stability studies according to ICH guidelines for drug development and follow-up stability studies, covering all ICH standard storage conditions as well as low temperature storage. All our processes take place on one connected site, where there is a high degree of QC ex...
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Product Betahistine diHCl
Grünenthal GmbH offers a selected range of products which includes Betahistine diHCl, as API, bulk tablets and/ or finished dosage form. Please contact us for more information.
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Product Biologic drug substance CDMO services
From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
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Product Quality control: Pharmaceuticals
Conscio offers GMP-certified and ICH-compliant chemistry, manufacturing and controls assays (CMC) as well as analytical support during validation of manufacturing processes. Samples are analyzed by approved and validated methods for routine batch testing, stability studies, analyses of high potency product...
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Product QACS Pharmaceutical services
QACS Lab is GMP/GLP certified and provides contract laboratory testing for Pharmaceuticals. Methodologies stay in accordance with EMA & FDA. QACS is equipped with Microbiological - Chemical - Molecular - Packaging laboratory premises to provide variety of Pharmaceutical testing solutions &...
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Product Analytical Development
Recipharm offer analytical support for drug discovery, pharmaceutical development and manufacturing through our global development facilities.
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Product FPFs
• Genexol®PM Inj.(Paclitaxel) • Genexol® Inj.(Paclitaxel) • Nanoxel®M Inj.(Docetaxel) • Docetaxel Inj.(Docetaxel) • Nexatin® Inj.(Oxaliplatin) • Everose® Tab.(Everolimus) • Pemed®S Inj.(Pemetrexed) • Azalid® Inj.(Azacitidine) • Decilid® Inj.(Decitabine) • Lenalid® Inj.(Lenalid...
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Product GALENIC DEVELOPMENT
TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing
GALENIC DEVELOPMENT
• Preformulation studies.
• Design and galenic develop...
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Product Complex drug formulation
We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...
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Product Development & Manufacturing by Contract
IntelGenx offers full service to foster the growth of its partners. Our State-of-the-art facilities are equipped with the most modem equipment to deliver high-quality, cost-effective film products, while accommodating client requirements at each stage of product development. Int...
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Product Analytical Services & EU Batch Certification
Method Development and validation
Stability Studies
European testing & batch certification
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Product Analytical Services & Methods
CritiTech provides a suite of material characterization and analytical services to support our clients drug development projects from proof-of-concept through cGMP production. Our testing data and documentation is reviewed by experienced technical and quality staff to ensure it can be used to support regul...
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Product Tramadol HCl
Grünenthal GmbH offers a selected range of products which includes Tramadol HCl, as API, bulk and/ or finished dosage form. Please contact us for more information.
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Product Extractables and Leachables Testing Services
Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, &l...
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Product Physical characterization techniques for pharmaceuticals
Intertek offers wide range of pharmaceutical services which includes physical characterization techniques for pharmaceuticals. Our experts can assist with formulation or process development, quality control, gmp lot release testing, and investigational manufacturing troubleshooting. It includes microscopy,...
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Product Formulation Development
Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.
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Product Pharmaceutical Impurity Analysis and Identification Testing
Our GMP compliant laboratories provide pharmaceutical impurity testing for new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) that can support your product development from an early stage and across the lifecycle of your drug product. Our scientists are adept at method routinely overcome...
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Product Stability Studies
QACS Labs offer drug development services. Pharmaceutical testing includes pharmaceutical stability testing, storage stability services and custom solutions based on international standards. We test API’s, raw materials and final products in recommended environmental storage conditions such as Temperature,...
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Product Mikromol custom reference standards
Creating pharmaceutical reference standards to customer specification has always been at the heart of the Mikromol business. We understand that you are constantly discovering new actives and impurities of interest - each year, our dedicated, highly-qualified customs team produces several hundred new materi...
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Product Stability Storage Testing
As the evaluation of stability is a critical aspect of drug substance and drug product testing, Integrated Analytical Laboratories offers Stability Services and Sample Testing to our partners. Whether you have predetermined stability protocols or require IAL to develop the protocol, IAL will be an im...
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Product Walk-In Cold Chamber (Cooling Cabinet)
Allyone has a long & rich experience of manufacturing state of the art Cooling Cabinets/ Cold chambers which are the most trustworthy equipment maintaining the exact set point, assuring absolute uniformity as they are meticulously designed & built for optimum performance keeping in mind environment...
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Product Laboratory Services
Laboratory Services
Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-related products. In addition to developing and validating analytical methods, batch-...
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Product Stability and Ageing Studies
The Quasaar Stability Centre offers flexible and large-volume storage facilities, which also allow the storage of voluminous packaging units (pallets) up to bulk goods. In addition to conducting ICH studies, it is also possible to place ageing studies, e.g. of medical devices. In this context, leakage and ...
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Product Wasdell Laboratory Services
By the end of 2017 we will have a MHRA, GMP licenced laboratory. We will be offering a wide range of services for routine Quality Control analysis including QC release testing, method validation and stability analysis (analytical and microbiological). We work to the highest standards of GMP and GLP with r...
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Product Stability
Study Types-In-use studies (broaching, reconstituted product stability, multi-use container stability)
-Formulation development studies including stress studies
-Photostability (Options I and II)
-Comparator studies
-Thermal cycling/freeze thaw
-Shipping excursion studies
-Long-term stabi...
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Product Analytical package
XEDEV provides a broad range of analytical tools including : • Solid state analysis: mDSC, XRPD, PLM, TGA, FTIR, RAMAN • Powder characterisation : SEM, PSD (both wet and dry), flowability • Tablet characterisation : friability, disintegration, hardness, dissolution • Residual solvent determination :...
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Product Pentapharm® BlisterPro® XCEL Services
Imagine design and prototyping Services that enable accelerated market introduction with increased accuracy in stability testing using the most cost-effective blister film to meet your requirements. Contact us for more information.
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Product Stability Testing
From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 2...
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Product Drug Release Studies/In Vitro Release Testing (IVRT)
MedPharm leverages its 20 years of experience to help develop and validate IVRT methods for its clients. We successfully perform IVRT based on FDA and EMA guidelines and continue to influence how these methods are utilized in regulatory submissions.
IVRT is the established method recogniz...
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Product Walk-In Stability (Humidity) Chamber
Allyone's Stability Chambers have a reputation to quickly achieve & maintain the defined setpoint to simulate the condition perfectly & flawlessly with extraordinary control on both Temperature & Humidity along with outstanding uniformity.
Our Stability Chambers are conceptual...
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Product Biopharmaceutical Product Related Impurities Analysis
To address the challenges of product related impurities including truncated and other modified forms, aggregates, precursors and other degradation products arising during processing and/or storage, we deliver detailed characterization in reference to the ICH Q6B Guidance using a diverse range of techn...
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Product Stability Testing
With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability conditions. These are fully controlle...
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Product Prism-G™ Capsules
Qualicaps provide wide range of capsules products includingprism-g™ capsules. Features: provide the ability to use a universal capsule for studies while allowing flexibility for final selection of product trade presentation,features a wide-range of colorants that can be extracted when your final trade...
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Product NanoLab 3D
Error-free particle sizing even at high concentrationConventional DLS instruments carry the risk that multiply scattered light can lead to incorrect particle size measurements without ever warning you. Especially with concentrated samples, complex sample preparation and dilution is necessary. This is exact...
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Product Stability/Ageing Studies
Stability/Ageing Studies: 500 m3 to 2000 m3 ICH-Climates
The Quasaar Stability Centre offers flexible and large-volume storage facilities, which also allow the storage of voluminous packaging units (pallets) up to bulk goods.
In addition to conducting ICH studies, it is also pos...
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Product Pharma Services / LDS
The Pharma Servicdes / Lichtenheldt development Department (LDS) accompanies and advises our customers from product idea through galenic development and through the registration into the routine production. For product development and scale up Lichtenheldt has its own dedicated staff and laboratories, ...
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Product Stabiity Storage and Analysis
Stability studies for drug substances and products as per ICH Guidelines • Under investigation samples • Under approval samples • Developmental / market / production samples Assistance in protocol design, on-going sample testing and trend analysis during and at conclusion of stability testing
• Acc...
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Product Anklam Extrakt Poduct Portfolio
• Premium Extracts – for your project Our extract portfolio includes both extracts in line with the ISO 22000 and/or Ph.Eur monograph for the pharmaceutical industry, and extracts for the food industry. From A for Althaea (marshmallow) to V for Vaccinium (cranberry) - we offer you a sophisticated and inn...
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