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Consultancy for drug/MD/food development

Consultancy for drug/MD/food development
Product Description

Our expertise offered in regulatory submissions and knowledgeable strategic skills in planning non-clinical testing programmes can reduce attrition rate and speed up the process.

galileo research

  • IT
  • 2023
    On CPHI since
  • 2
    Certificates
  • 1 - 24
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Contract Research Organisation
Specifications
  • Model
    Regulatory support: (Common technical document module 2.4, 2.6, 4; toxicological and pharmacological expert reports; PDE reports; Biological Evaluation Plan and Report.

galileo research

  • IT
  • 2023
    On CPHI since
  • 2
    Certificates
  • 1 - 24
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Contract Research Organisation

More Products from galileo research (4)

  • Biocompatibility of Medical Devices according to ISO 10993-1 series

    Product Biocompatibility of Medical Devices according to ISO 10993-1 series

    Galileo Research can drive the nonclinical development of your medical device by preparing the Literature Report and the Biological Evaluation Plan (BEP) according to ISO 10993-1, performing additional tests, if needed, and releasing the Biological Evaluation Report (BER).

    All tests can be condu...
  • Drug efficacy, In vitro and in vivo studies

    Product Drug efficacy, In vitro and in vivo studies

    We offer a full range of studies and bioanalytical services, providing powerful tools and rigorous solutions for preclinical drug development of therapeutic candidates, advance lead compounds towards first-in- human trials, and support for ongoing clinical development
  • Drug safety, in vitro and In vivo studies

    Product Drug safety, in vitro and In vivo studies

    In support of human clinical trials and marketing authorization approval, Galileo Research offers a full battery of toxicity studies for the regulatory development of small drugs, as well as biologics and advanced therapies, in compliance with Good Laboratory Practice (GLP), ICH and OECD guidelines.

  • Food safety evaluation

    Product Food safety evaluation

    Potential benefits and safety of dietary supplements need to be assessed by scientifically validated means, in the context of Regulation (EC) 2015/2283 on novel foods. Toxicological data, including genotoxicity, information on absorption, distribution, metabolism and excretion (ADME) need to be collecte...

galileo research resources (2)

Frequently Viewed Together

  • Product Vendor Qualification and Audit

    Our pool of auditors have experience in a wide range of dosage forms and processes, medical devices, API, Excipient, laboratories, storage sites and service providers.  Each auditor is selected according to their expertise and experience and is assessed for suitability before engaging in a client ...
  • 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 Track & Trace Pharma Compliance Solution

    The most modular, flexible and comprehensive solution covering Track & Trace compliance at all levels: enterprise (level 4), production plant, packaging line and warehouse, to ensure traceability compliance for EU-FMD, DSCSA and any other regulatory requirement for pharmaceutical products. A platfo...
  • 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 Compliance Management

    PharmSol does not limit itself only to offering Audits, but we expand our solution offerings to ensure complete Compliance at the client's site. Towards obtaining GMP Certification from Europe, United States or WHO, PharmSol has a very effective, systematic and rational approach in providing solutions effi...
  • 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 GMP-Support: Qualification / Validation / Consulting

    Quasaar does not see itself as "processing office" of service contracts.

    As an outsourcing partner, Quasaar also focuses on problem solving, increasing efficiency and process optimization, including on-site consulting and project management.
    Our expertise includes i.a. following topics: ...
  • Product Development

    Synerlab provides wide range of services which includes development. Contact us for more information.
  • Product Biocompatibility of Medical Devices according to ISO 10993-1 series

    Galileo Research can drive the nonclinical development of your medical device by preparing the Literature Report and the Biological Evaluation Plan (BEP) according to ISO 10993-1, performing additional tests, if needed, and releasing the Biological Evaluation Report (BER).

    All tests can be condu...
  • Product GCP Services(Good Clinical Practices)

    We offer various GCP services which can help the clients across globe, ranging from audits to monitoring services. We provide comprehensive GCP Quality Compliance services to the pharmaceutical industry. Our GCP consulting services are characterized by:

    1) Knowledge: Various regulatory requi...
  • Product Training

    Our Subject Matter Experts provide training that fulfill all regulatory requirements

    Training is an integral part of GMPs. The operations involved in the manufacture of regulated products are highly technical in nature. Inadequate training of personnel can result in products failing to meet the ...
  • Product Engineering

    We help bring concept ideas to life

    PharmEng engineers are experienced in building scalable and robust pharmaceutical production facilities and processes while employing state of the art techniques to meet and exceed operational and regulatory requirements.

    Our experts have succes...
  • Product Regulatory Support

    Our Chemistry, Manufacturing and Controls (CMC) specialists help customers manage the product's compliance at every step, from clinical development to market authorization. With decades of experience, our experts provide support in navigating regulatory milestones, including site registration, product regi...
  • Product GxP Training Services

    We work with our clients to ensure that the correct quality culture is embedded in their organisation by training the staff in the core principles of GMP, GDP, or other GxP industry practices.  When your employees understand the core principles of your quality system and the consequences of non-c...
  • Product Contract QP, RP and RPi Services

    QPs are available to be listed on client MIA/MIA-IMPs and carry out batch release according to Directive 2001/83/EC (Human), Regulation (EU) No 536/2014 (clinical) and Regulation (EU) 2019/6 (veterinary).For GDP and distribution, we provide interim RP and RPi services to the pharmaceutical indust...
  • Product QMS Authoring and Licencing Support

    We can help you design and implement effective quality management systems that comply with current EU and UK GxP standards.

     An effective QMS will consist of all of the business processes, personnel responsibilities and standards including manuals, policies and procedures required to...
  • Product Drug efficacy, In vitro and in vivo studies

    We offer a full range of studies and bioanalytical services, providing powerful tools and rigorous solutions for preclinical drug development of therapeutic candidates, advance lead compounds towards first-in- human trials, and support for ongoing clinical development
  • Product Autoinjector development expertise and capabilities

    SHL Medical's commitment to innovation has driven our leadership in the drug delivery industry. We offer vertically integrated expertise and capabilities to ensure the production of our self-injection systems are delivered with unparalleled speed, quality, and reliability. 

    Learn more about SHL...
  • Product GMP Services(Good Manufacturing Practices)

    We offer various GMP services which can help the clients across globe, ranging from audits to various consulting services.

    We provide following comprehensive GMP Quality Compliance services to the pharmaceutical industry.

    • Audits 

    • API Audit Reports 

    • QMS/Complia...
  • Product Regulatory Support

    Zenovel has a highly experienced team of experts who have a complete understanding of the complete requirements of Pharma Regulatory affairs throughout the drug life cycle. Our experts have experience in directly corresponding with Pharma regulatory authorities for various segments.
    ...
  • Product Regulatory, CMC and MA sourcing

    We provide regulatory and PV services, which can be tailored to suit individual client needs.
    Our regulatory support includes Marketing Authorisation sourcing, MA transfer, ongoing licencing support, CMC authoring and preparation of type I and type II variations and submission to EMA and national he...
  • Product Project Management

    Our experts incorporate the most modern and efficient Project Management techniques to ensure all project goals and objectives are met

    PharmEng Technology has recognized that Project Management is essential throughout the Pharmaceutical, Biotechnology, and Medical Device industries.
    ...
  • Product Drug safety, in vitro and In vivo studies

    In support of human clinical trials and marketing authorization approval, Galileo Research offers a full battery of toxicity studies for the regulatory development of small drugs, as well as biologics and advanced therapies, in compliance with Good Laboratory Practice (GLP), ICH and OECD guidelines.

  • Product Regulatory Affairs

    We provide solutions to meet both local and global regulatory requirements in the most cost-effective manner.

    PharmEng supports Pharmaceuticals, Biologics, Over-The-Counter (OTC), Animal Health, Radiopharmaceuticals, Clinical Trial Products, Medical Devices, Combination Products, Natur...
  • Product Local Regulatory Compliance in over 130 countries

    - Regulatory Affairs Consulting for FDA, EMA, MHRA, TGA, Health Canada, ANVISA, NMPA, PMDA, MCC, SAHPRA, and other NRAs - Pharmaceutical Drug Market Authorization, Biotech, Pharmacovigilance, Pre-Sub, IND, ANDA, NDA, BLA, Establishment Registration - QA Pharma, GMP, GCP, GLP, GDP pre-audit -...
  • Product Commissioning & Qualification

    Our qualified consultants strive to exceed your project goals and objectives

    Our flexibility and project experiences range from the qualification of an individual piece of equipment to an entire facility.
    Our PharmEng professionals have extensive experience in the development, imple...
  • Product Food safety evaluation

    Potential benefits and safety of dietary supplements need to be assessed by scientifically validated means, in the context of Regulation (EC) 2015/2283 on novel foods. Toxicological data, including genotoxicity, information on absorption, distribution, metabolism and excretion (ADME) need to be collecte...
  • Product Medical Writing

    Emtex offers worldwide professional medical writing and related services to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions.
  • Product Regulatory Sciences

    From early-stage development to post-approval, we partner with pharmaceutical, biotechnology, and medical device clients to overcome regulatory hurdles. Using science as the driver for success, we help our clients achieve positive regulatory outcomes with the Food and Drug Administration (FDA), Europea...
  • Product Automation Engineering Solutions

    We provide solutions and technologies that reduce human intervention and increase efficiency.

    Automation is offered in DCS projects independent of the automation vendor. We offer professional services in implementing Automation process control and maintenance in accordance with industry standards ...