Method Development and Validation

Method Development and Validation
Product Description

GBA Gesellschaft für Bioanalytik mbH provides wide range of pharmaceutical analysis services which includes Method Development and Validation. The development and validation of a new method often seems to be hard and complex. Prior to the start, a lot of facts have to be considered. Beneath the availability of qualified personal the performance of the new method has to meet internal and general quality guidelines and should be suitable for everyday use. Especially with biotherapeutics, you are forced to follow new analytical paths, as new synthetic pathways are explored continuously.. Contact us for more information.

GBA Group Pharma

  • DE
  • 2015
    On CPHI since
Specifications
  • Selling Points
    Experienced Technicians; Quality Service; Reputation
  • Supplied from
    Germany

GBA Group Pharma

  • DE
  • 2015
    On CPHI since

More Products from GBA Group Pharma (2)

  • Quality Control

    Product Quality Control

    GBA Pharma provides wide range of pharmaceutical analysis services which includes Quality Control. It includes: Testing of packaging materials; Implementation of analytical methods including transfer, monitoring and reporting; Testing of semi-finished goods; Testing of small scale batches and batches from ...
  • EU Import & QP Services

    Product EU Import & QP Services

    EU QP release
    QP declaration
    IMP release
    Quality advisor GMP, GCP, GDP, GLP
    GMP consulting Audits of CMOs
    Preparation / revision of batch records & SOPs
    QP backup services

GBA Group Pharma resources (1)

Recommended Products

  • Product Development and Validation of Analytical Methods

    Analytical methods development and validation: Our method development scientists work with a broad range of products, methods, and analytical technologies (chromatography, mass spectrometry, spectroscopy, biophysical analysis, bioanalytical techniques, etc.) to ensure that the method will meet its int...
  • 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 &...
  • Product Development

    Synerlab provides wide range of services which includes development. Contact us for more information.
  • 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...
  • 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-...
  • 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, ...
  • Product Medical Devices for various medical procedure (HA injection syringes acc...

    De l'idée à la conception, l'industrialisation jusqu'à la qualification et la production.
    From the idea trough the design, industrialization until qualification and production.
  • Product CHEMICAL ANALYSIS DEPARTMENT

    Spark-Lab Chemical Analysis Department performs qualitative and quantitative analyses in response to the needs of, above all, the chemical industry and related sectors. Research is carried out with the use of high-end, qualified measurement equipment. Routine analyses carried out in Spark-Lab me...
  • Product Analytical services

    Analytical services 

    In addition to the basic product quality control, the following connected services are offered, which are required throughout the product development or before the market launch of the respective products:

     

    GMP for excipients, risk assessment...
  • Product Development Service

    Lomapharm GmbH provides wide range of services which includes development service. It provides the whole range of control services - from raw material testing to stability testing according to GMP and ICH regulations. One of the main areas of competence and experience is also available for galenic dev...
  • Product Biocompatibility & Toxicology Testing

    Nelson Labs offers a full trifecta of services to meet the requirements of ISO 10993 for Extractables & Leachables, Biocompatibility and Toxicological Assessments of medical devices. Biocompatibility testing is very common in the medical device industry. However, with 24 possible categories, each with...
  • Product Analytical Testing and Formulation Development

    Quality Chemical Laboratories is known for its capabilities in the development and validation of analytical methods for raw materials, drug substances, and drug products. With a strong focus on quality and precision, QCL employs cutting-edge technologies and a highly skilled team of scientists to offer com...
  • Product Analytical services - OEL: 50 ng/m3

    • Control of pharma samples solid state : Identification and quantification of solid state, method development and validation, routine QC. • Analytical techniques available : XRPD, DSC, TGA, DVS, Laser PSD, FTIR, IDR. • All analyses are applicable to toxic samples down to : 50 n...
  • 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...
  • 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...
  • 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 :...
  • Product Drug Development Services

    Aurigene Pharmaceutical Services offers a wide range of chemical development services for pharmaceutical, agrochemicals, fine chemicals and animal health industry. We support the development of Key Starting Materials (KSM) / Registered Starting Materials (RSM), advance intermediates and APIs from the ...
  • Product Method Development, Optimization, and Validation Services

    At Integrated Analytical Laboratories (IAL), our approach to method development helps reduce bottlenecks and reduces errors. We understand time is of the essence, so IAL provides a consultative approach with our partners to ensure that your new drug product will meet the goals and objectives you a...
  • Product Consulting: Quality Management System

    Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr...
  • Product Method Validation

    Neotron Pharma is able to validate analytical methods developed internally or transmitted by the customer using top of the range equipment such as:
    - HPLC-UV / DAD / MSMS
    - GC-FID / ECD / MSMS (even in Headspace)
    - ICP-MS / AAS / AES / OES
    - Post-column derivatization
    - Particle si...
  • 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, ...
  • Product Scale-Up and Transfer of lyophilization processes

    From the laboratory to the industry. 

    The key to a correct Scale-Up and Transfer of lyophilization processes is the knowledge of the developed product, as well as the control of the process and the capabilities of the final equipment.
  • Product Innovation & Formulation

    Innovation & Formulation: We offer pharmaceutical R&D, feasibility studies, proof-of-concept, formulation development and analytical method development for multiple dosage forms such as solids, semi-solids, liquids, oral films, and transdermal patches. We can work with over 30 pharma technologies f...
  • Product Method Development, Validation and Transfer

    Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes method development, validation and transfer. Kymos has comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary method...
  • Product UTPVision LAT 313 ACCREDIA

    The UTPVision LAT 313 is a calibration centre accredited by ACCREDIA and it’s able to issue calibration certificates with the guarantee of metrological traceability to the International System of Units.
    Discover more: https://utpvision.com/it/certificazioni-accredia/
  • Product Formulation Development

    Our Formulation Scientists and Process Engineers are experts in poorly soluble compounds and high containment operations. Our formulation development lab and pilot plant suites are specifically designed for high containment and outfitted with cGMP matching technologies. We follow a data driven approach to ...
  • Product Automated Leak Testing for Sterile Pharmaceuticals

    Our automated CCI testers for vials, syringes, ampoules, blow-fill-seal containers, IV bags and other pharmaceutical packaging use the latest generation of differential pressure testing or headspace analysis procedures allowing a highly sensitive and robust measurement.

    Highlights: • Indus...
  • Product COMMISSIONING & VALIDATION

    CTP SYSTEM supports its customers in managing and directly performing all the Validation phases and Qualification activities for all kinds of equipment, systems and utilities in Pharmaceutical and related companies. 
    We have extensive experience in the preparation of Validation Master Plans at ...
  • Product elogbook : Harmonized logbooks.

    Presenting Electronic Logbook, complying with 21 CFR Chapter 11 requirements, a simple yet controlled platform for all Pharmaceutical manufacturing to manage logbooks, digitally.

    Complying with GMP guidelines, Electronic Logbook provides capability of defining flexible workflow, SOPs on area...
  • 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...
  • Product Elemental Analysis and Trace Metals (ICH Q3D, USP 233/232)

    We provide pharmaceutical organic and inorganic elemental analysis from trace levels to percent levels. Trace metals testing is a routine activity for our Good Manufacturing Practice (GMP) laboratories and is carried out in accordance with pharmacopeia methods such as the United States Pharm...
  • Product R&D Research and Development

    The Pharmaceutical Analyses Department of Spark-Lab conducts research and development work in cooperation with pharmaceutical and cosmetics manufacturing plants. The Laboratory provides services through its highly skilled personnel and state-of-the-art equipment at the initial phase of works on a g...
  • Product Inhalation Drug Product Development Services

    Services for the development of inhalation drugs: Our team have over 30 years of experience supporting our clients' product development for orally inhaled or nasal drug products (OINDP). This includes formulation, stability, testing, product performance testing, in vitro bioequivalence studies, CMC...
  • Product Packaging Solutions Testing

    We offer unparalleled breadth of packaging experience to help our clients deliver safe and effective products to market. Our services encompass consulting, package validation, material qualification and package development. Nelson Labs packaging solutions department has experience with successful valida...
  • Product Validation of AI and non-AI technologies for Life Science companies

    We specialize in AI and non-AI Computer System Validation, equipment validation, utility qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA, and other key Life Science authorities across Europe and the Americas. We are a ...
  • Product Extractables & Leachables Testing

    Nelson Labs Europe offers a comprehensive approach toward Extractables & Leachables testing for the pharmaceutical industry. Our approach combines technical and analytical expertise, polymer knowledge and understanding of regulatory requirements, all combined in a tailored approach for our customers.
  • Product Validation

    Our team of experts will prepare necessary protocols incorporating all critical parameters


    Process Validation:

    PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...
  • Product Analytical research & development

    Our analytical experts know what it takes to bring a pharmaceutical product to the market, from discovery, feasibility to GMP. Having worked with more than 100 unique molecules and even more formulations, we may state that we have faced the most difficult CMC challenges that are involved.
    ...
  • Product Wireless data monitoring system- testo Saveris

    testo Saveris - Data monitoring systems with automated and uninterrupted measurement data recording of temperature and humidity values in the environment and in processes. Offers centralized documentation as well as an alarm function thusly saving time. It guarantees the safety of your measurement data...
  • Product Ghost-Buster

    Welch Ghost-Buster column can efficiently adsorb and remove the impurities from the mobile phase to eliminate their interference to the target peaks. 
  • Product INSTRUMENT CALIBRATION

    For the calibration of the instruments, Adeodata stands out for its competence and organization. Adeodata guarantees the use of reference instruments with the necessary accuracy and referable to international standards that allow it to calibrate the instruments, not only in the mos...
  • Product Research Services - Drug Discovery

    PMI Bio’s talented Research team provides extensive protein science services that include small projects such as expressing and purifying a single protein to biochemical and biophysical support for multiyear discovery campaigns.  Our experienced team of scientists uses multiple techniques includin...
  • Product BOTULINUM NEUROTOXINS TYPE A AND B

    SciencePharma, acting on behalf of its client - Nova Pharma Sp. z o.o., would like to kindly invite to negotiate rights acquisition to the documentation of development of the method for the production and purification of botulinum neurotoxins type A and B.
    The project was carried out within Ope...
  • Product Equipment Validation, agile and digital method

    We specialize in Computer System Validation, equipment validation, utilities qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA and other key Life Science authorities across Europe and the Americas. With a proven track r...
  • Product Quality Control

    GBA Pharma provides wide range of pharmaceutical analysis services which includes Quality Control. It includes: Testing of packaging materials; Implementation of analytical methods including transfer, monitoring and reporting; Testing of semi-finished goods; Testing of small scale batches and batches from ...
  • Product Method Development & Validation Services

    Neopharm Labs has two distinct validation departments; Chemistry and Microbiology. Each validation department is dedicated to the development, validation, verification, recovery and inter-laboratory transfer of analytical methods. Typical samples include raw materials, API, finished products, cleaning and ...
  • Product Analytical Services

    Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)
  • Product Analytical Development

    Idifarma’s analytical development services include the following activities:
    - Solubility studies in different media (organic, aqueous and different PH levels).
    - Characterization of the thermal profile and identification of polymorphic forms by DSC.
    - Impurities profile characterization. q...
  • Product Method validation

    Intertek offers wide range of pharmaceutical services which includes method validation. It belongs to bioanalytical services for preclinical and clinical studies category. Contact us for more information.
  • Product Chemical Development Solutions

    Chemical Development Solutions of GVK BIO provides a convenient, single-site distribution of infrastructure, thereby delivering a seamless and innovative transition of solutions from lab to pilot plant and bulk manufacturing, with speed and quality.

    We ensure quality in the process during th...