loader
Please Wait
Applying Filters...

Market Place

Market Place

Market Place

Menu

Post Enquiry

Post Enquiry

PharmaCompass

Home

Market Place

Market Place

Search
All
API
FDF
Price
Services
Excipients
Enquiries

    Find

    • Active Pharmaceutical Ingredients Active Pharmaceutical Ingredients
    • Finished Drug Formulations Finished Drug Formulations
    • Price Price
    • Excipients Excipients
    • Services Services
    • Market Place Marketplace

    Market Place

    Market Place

    Post Enquiry

    Post Enquiry

    Clinical trials are conducted to collect the data necessary to provide information for an investigating drug to reach the market. To ensure investigators are following the protocol, complying with regulatory and Good Clinical Practice (GCP) standards, and collecting and reporting quality data, sponsors of clinical trials monitor the progress of clinical trials performed by the investigators during the clinical trial. Quality and compliance assurance services help the clients to ensure the integrity of their clinical trials. In addition to providing in-house quality assurance auditing for clinical trial sites, CROs and third party vendors, we help clients to protect research subjects’ rights and welfare, verify the integrity of data and ensure adherence to protocols and international regulatory guidelines. Pharmaceutical organization which provides ICH GCP investigator training and clinical compliance certified by the regulatory agencies. Their GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by Trans Celerate BioPharma as necessary to enable mutual recognition of GCP training among trial Sponsors. Some crucial quality and compliance services for clinical trials are- Vendor audits, assessments and qualifications, including GDP depot audits, in which we evaluate a client’s vendors to ensure they have sufficient capacity and capability to deliver quality based services on time and in compliance with regulations, Clinical investigator site audits (Phase I/Bioequivalence facilities and clinical trials, Phase II-III clinical trials, post-marketing activities, routine, for-cause and pre-inspection audits to help sites prepare for regulatory agency reviews, Clinical study document audits and reviews, Clinical investigator site compliance visits, GCP and GVP quality system audits, in which we assess client internal processes, standard operating procedures (SOPs), staff training programs, as well as provide recommendations for improvement, Safety surveillance/pharmacovigilance audits. To maintain the compliance of clinical trials companies follow the following points of quality, Creating, implementing, and upholding standard operating procedures (SOPs) for trial execution, A quality scientific and medical design of the protocol, Clinical investigator and site pre-assessment and selection, Regulatory agency and ethics committee approval, Developing and providing appropriate informed consent (language, transparency of benefits and risks) and obtaining ethics committee approval of the informed consent process, Investigator meetings and training, Adequate recording and reporting of data, Periodic monitoring, timely audits. The Clinical Study Report (CSR) is the report that summarizes the clinical data. It includes the entire protocol, sample case report forms, investigator information, all information related to the investigational product being studied as well as any statistical analyses, publications, tables or other data. It is an integrated report that contains all study related information and is provided to regulators, after conclusion of every study. In the CSR, questionable data is typically removed from the efficacy portion of the study analysis, to ensure that such analysis is reliable, and the report will explain why this data was excluded. The data may still be used for safety analyses. In some instances the study analysis is performed with and without the questionable data to provide the regulators with both results for consideration. Transparency of both the data, and the processes for analyzing the data is essential for regulators to understand the ethical conduct of the trial.

    adare-pharmaceuticals-Default-Wallpaper
    adare-pharmaceuticals-Default-Wallpaper
    Previous
    Next
    Filters Filter
    ×
    FILTER DATA :

    filter

    Chiltern International Ltd

    Factory CRO

    Greenleaf Health Inc

    KAI Research

    Lovelace Scientific Resources

    Mapi Group

    Pharmaceutical Product Development, LLC

    TFS International AB

    filter

    SWEDEN

    UNITED KINGDOM

    UNITED STATES

    Factory CRO

      Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

      UNITED STATES United States

      Contact Supplier Post An Enquiry

      Virtual Booth Virtual Booth

      BE PHARMA 2020

      Participation Not Confirmed

      Update your events

      CE Marking

      Supporting Information: Click here to upload a PDF
      Link Icon Link to Supplier Content
      Contact the Supplier

      - Service Details

      We are well acquainted with CE-marking studies and can assure that your study can be designed and controlled to meet the demands of Notified Bodies.

      - Directory Listing

      Pharma Service: Clinical Trials

      Category: Compliance, Regulatory & Consulting

      Sub Category: Quality & Compliance

      Lovelace Scientific Resources

        Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

        UNITED STATES United States

        Contact Supplier Post An Enquiry

        Virtual Booth Virtual Booth

        BE PHARMA 2020

        Participation Not Confirmed

        Update your events

        Quality Assurance

        Supporting Information: Click here to upload a PDF
        Link Icon Link to Supplier Content
        Contact the Supplier

        - Service Details

        When contracting with LSR Trials, you can be assured that we will meet all deadlines and the data will be immaculate to ensure a successful trial.

        - Directory Listing

        Pharma Service: Clinical Trials

        Category: Compliance, Regulatory & Consulting

        Sub Category: Quality & Compliance

        Mapi Group

          Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

          UNITED STATES United States

          Contact Supplier Post An Enquiry

          Virtual Booth Virtual Booth

          BE PHARMA 2020

          Participation Not Confirmed

          Update your events

          Quality & Regulatory Support

          Supporting Information: Click here to upload a PDF
          Link Icon Link to Supplier Content
          Contact the Supplier

          - Service Details

          Mapi provides customers with assistance on quality and compliance matters, including pharmaceutical quality assurance, medical device quality systems, and clinical compliance (GCP).

          - Directory Listing

          Pharma Service: Clinical Trials

          Category: Compliance, Regulatory & Consulting

          Sub Category: Quality & Compliance

          TFS International AB

            Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

            SWEDEN Sweden

            Contact Supplier Post An Enquiry

            Virtual Booth Virtual Booth

            BE PHARMA 2020

            Participation Not Confirmed

            Update your events

            Preparation & Submission of CTA/ITA, IND, PMA...

            Supporting Information: Click here to upload a PDF
            Link Icon Link to Supplier Content
            Contact the Supplier

            - Service Details

            The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

            - Directory Listing

            Pharma Service: Clinical Trials

            Category: Compliance, Regulatory & Consulting

            Sub Category: Quality & Compliance

            Factory CRO

              Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

              UNITED STATES United States

              Contact Supplier Post An Enquiry

              Virtual Booth Virtual Booth

              BE PHARMA 2020

              Participation Not Confirmed

              Update your events

              International Clinical Trial Rescue

              Supporting Information: Click here to upload a PDF
              Link Icon Link to Supplier Content
              Contact the Supplier

              - Service Details

              We are proud to offer our early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators.

              - Directory Listing

              Pharma Service: Clinical Trials

              Category: Compliance, Regulatory & Consulting

              Sub Category: Quality & Compliance

              KAI Research

              • FDA

              Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

              UNITED STATES United States

              Contact Supplier Post An Enquiry

              Virtual Booth Virtual Booth

              BE PHARMA 2020

              Participation Not Confirmed

              Update your events

              Quality Assurance of Trials

              Supporting Information: Click here to upload a PDF
              Link Icon Link to Supplier Content
              Contact the Supplier

              - Service Details

              Our long experience in validating clinical studies has allowed us to strengthen internal procedures to maximize accountability, systematic feedback, and quality control in all aspects of studies and data handling.

              - Directory Listing

              Pharma Service: Clinical Trials

              Category: Compliance, Regulatory & Consulting

              Sub Category: Quality & Compliance

              Factory CRO

                Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

                UNITED STATES United States

                Contact Supplier Post An Enquiry

                Virtual Booth Virtual Booth

                BE PHARMA 2020

                Participation Not Confirmed

                Update your events

                FDA Regulatory Strategy

                Supporting Information: Click here to upload a PDF
                Link Icon Link to Supplier Content
                Contact the Supplier

                - Service Details

                Factory’s team has a broad and in depth knowledge on FDA requirements and procedures and can help you design a regulatory strategy specific for your device.

                - Directory Listing

                Pharma Service: Clinical Trials

                Category: Compliance, Regulatory & Consulting

                Sub Category: Quality & Compliance

                Greenleaf Health Inc

                  Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

                  UNITED STATES United States

                  Contact Supplier Post An Enquiry

                  Virtual Booth Virtual Booth

                  BE PHARMA 2020

                  Participation Not Confirmed

                  Update your events

                  FDA Communications

                  Supporting Information: Click here to upload a PDF
                  Link Icon Link to Supplier Content
                  Contact the Supplier

                  - Service Details

                  Greenleaf provides evaluation and response recommendations for: Facility and supply chain audit reports; cGMP deficiency letters; Establishment inspection reports (EIRs)nFDA Form 483s; Warning letters; Untitled letters; Other compliance- and enforcement-related actions.

                  - Directory Listing

                  Pharma Service: Clinical Trials

                  Category: Compliance, Regulatory & Consulting

                  Sub Category: Quality & Compliance

                  Chiltern International Ltd

                    Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

                    UNITED KINGDOM United Kingdom

                    Contact Supplier Post An Enquiry

                    Virtual Booth Virtual Booth

                    BE PHARMA 2020

                    Participation Not Confirmed

                    Update your events

                    Product Labeling Testing

                    Supporting Information: Click here to upload a PDF
                    Link Icon Link to Supplier Content
                    Contact the Supplier

                    - Service Details

                    Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

                    - Directory Listing

                    Pharma Service: Clinical Trials

                    Category: Compliance, Regulatory & Consulting

                    Sub Category: Quality & Compliance

                    Pharmaceutical Product Development, LLC

                    • FDA

                    Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

                    UNITED STATES United States

                    Contact Supplier Post An Enquiry

                    Virtual Booth Virtual Booth

                    BE PHARMA 2020

                    Participation Not Confirmed

                    Update your events

                    Clinical Quality & Compliance Services

                    Supporting Information: Click here to upload a PDF
                    Link Icon Link to Supplier Content
                    Contact the Supplier

                    - Service Details

                    PPD's clinical quality assurance (CQA) services help our clients ensure the integrity of their clinical trials. We advise clients on how to verify the integrity of scientific data and ensure adherence to protocols and international regulatory guidelines. We also help clients protect research

                    - Directory Listing

                    Pharma Service: Clinical Trials

                    Category: Compliance, Regulatory & Consulting

                    Sub Category: Quality & Compliance

                    Factory CRO

                      Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

                      UNITED STATES United States

                      Contact Supplier Post An Enquiry

                      Virtual Booth Virtual Booth

                      BE PHARMA 2020

                      Participation Not Confirmed

                      Update your events

                      European Regulatory Strategy

                      Supporting Information: Click here to upload a PDF
                      Link Icon Link to Supplier Content
                      Contact the Supplier

                      - Service Details

                      We would be happy to provide a free consultation about your European regulatory strategy, without any future obligation. We can assist with Notified Body selection and negotiations.

                      - Directory Listing

                      Pharma Service: Clinical Trials

                      Category: Compliance, Regulatory & Consulting

                      Sub Category: Quality & Compliance

                      TFS International AB

                        Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

                        SWEDEN Sweden

                        Contact Supplier Post An Enquiry

                        Virtual Booth Virtual Booth

                        BE PHARMA 2020

                        Participation Not Confirmed

                        Update your events

                        Global QA & Compliance

                        Supporting Information: Click here to upload a PDF
                        Link Icon Link to Supplier Content
                        Contact the Supplier

                        - Service Details

                        At TFS we strive to ensure costs are kept within the budget using our in-depth knowledge of international and local regulatory requirements and our network of global investigators to ensure that the trial objectives will be met on time.

                        - Directory Listing

                        Pharma Service: Clinical Trials

                        Category: Compliance, Regulatory & Consulting

                        Sub Category: Quality & Compliance

                        TFS International AB

                          Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

                          SWEDEN Sweden

                          Contact Supplier Post An Enquiry

                          Virtual Booth Virtual Booth

                          BE PHARMA 2020

                          Participation Not Confirmed

                          Update your events

                          Quality Assurance

                          Supporting Information: Click here to upload a PDF
                          Link Icon Link to Supplier Content
                          Contact the Supplier

                          - Service Details

                          TFS Quality Assurance (TFSQA), an independent group within TFS, is responsible for ensuring the quality of the work provided by TFS, and that all work is conducted in compliance with applicable GxP guidelines, relevant regulatory requirements and applicable Standard Operating Procedures (SOPs).

                          - Directory Listing

                          Pharma Service: Clinical Trials

                          Category: Compliance, Regulatory & Consulting

                          Sub Category: Quality & Compliance

                          PharmaCompass >>

                          First
                          Previous
                          Next
                          Last

                          Market Place

                          Market Place

                          PharmaCompass

                          Home

                          Market Place

                          Menu

                          Post Enquiry

                          Post Enquiry

                          Market Place

                          Market Place

                          Search