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Quality Management/ Safety/ Regulatory Services

Quality Management Safety Services Regulatory Services

 

Quality

Pleiad's highly skilled and truly independent quality management team offers a comprehensive range of services and expertise to assist you with your compliance and quality system objectives:

  • GCP Auditing Services
  • Application Integrity Policy (AIP) Support
  • Pre-clinical GLP Auditing Services
  • GMP Audits for Pharmaceuticals
  • Quality System Audits for Medical Devices
  • Computer System and 21CFR part 11 Audits
  • Quality System Development
  • Training

Pleiad's Comprehensive Auditing Capabilities

Pleiad conducts GCP audits utilizing a quality systems approach with an emphasis on the study protocol specifics and the applicable regulations (21 CFR Parst 11, 50, 54, 56, 312, 314, 812, ICH and local authority requirements). Pleiad's auditing expertise includes: North America and European Union.

GCP

  • Pleiad can assist with a comprehensive range of GCP audits:

    • Investigator sites
    • Service providers (CRO's EDC Data Management, Central Labs)

    • Sponsors (Inspection Readiness)

  • Pleiad's approach to conducting GCP audits includes the following deliverables:

    • Development of a Comprehensive Audit Plan
    • Summary of Findings Meeting
    • Audit report and Audit Certificate Issuance
    • Corrective Action Recommendations

AIP

  • Pleiad knows time is of the essence when your company is under application integrity hold. We can help!

  • Pleiad's auditing services group can support your independent auditor needs prescribed under the application integrity hold policy (AIP). Pleiad exercises a strategic approach to AIP projects by assigning a project manager that assembles and audit team to:

    • Develop a Draft Audit Plan for FDA approval
    • Upon Audit Plan Approval, organize and deploy Audit Teams
    • Establish database for collecting audit results
    • Report to and communicate with FDA as specified
    • Generate Audit Reports and forward to FDA as specified
    • Develop a comprehensive corrective action plan with the client to address deficiencies

GLP

  • Pleiad conducts GLP audits utilizing a research based quality systems approach with an emphasis on the protocol specifics and applicable regulations (21 CFR Parts 58 and OECD requirements). Pleiad can assist with a comprehensive range of GLP audits:

    • Pre-clinical Safety Study Reports
    • Pre-clinical Contract Research Organizations
    • Pre-clinical Inspection Readiness

    • QUA Support

  •  Pleiad's approach to conducting GLP audits includes the following deliverables:

    • Development of a specific Audit Plan focused on Critical Study Phases
    • Executing the Audit Plan
    • Summary of Findings Meeting
    • Audit Report and Audit Certificate Issuance
    • Corrective Action Recommendations

GMP & Quality Management Systems Development

  • Pleiad can assist you with your GMP auditing and quality system development needs to meet regulatory demands:

    • Medical Device quality system compliance, ISO 13485(2003), 21CFR 820, Medical Device Directive (MDD)
    • Pharmaceutical GMPs and Sterile Manufacturing
    • Clinical Trial Materials, (GMPs and EU Clinical Trial Directive)
    • Inspection readiness
    • Audits are conducted against all required regulations and client requirements
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Safety

Pleiad collects, logs, tracks and assesses all potentially reportable events that occur during a trial. Pleiad’s Safety Associates oversee the safety assessment process using a database for tracking, recording and  reporting events.  The medical monitor assesses all events for reportability and advises the client on safety issues if and when these arise. 

 
Pleiad undertakes any required expedited reporting of Serious Adverse Advents (SAEs), Unanticipated Adverse Device Effects (UADEs), and Suspected Unexpected Serious Adverse Drug Reactions (SUSARs).
 
Pleiad’s medical monitors are a part of our in-house team.

Management of Data Safety Monitoring Boards (DSMB) and Clinical Event Committees (CEC)

Pleiad selects DSMB participants based upon their therapeutic expertise and prior DSMB experience to best fit study needs. Pleiad plans and executes the meetings according to established data safety monitoring plans. This includes:

  • Establishing the operating procedures
  • Assembling DSMB review data packages
  • Preparing meeting minutes
  • Following up on action items

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Regulatory

Pleiad's regulatory expertise for medical devices encompasses the requirements for both North American and European Markets. This includes submissions to and interactions with the FDA, the EU Competent Authorities, and the EU Notified Bodies. The company supports IDE, 510k, PMA, CTA, IND, NDA, and CE mark applications.

Pleiad's Regulatory Team offers regulatory support for medicinal products from preclinical development through late phase clinical trial authorization (Phase I - III).

Regulatory Services - Medical Devices

Navigating the regulatory framework from medical device design to a global market approval can be challenging. Requirements for medical device approval are becoming increasingly complex due to the great advancement of medical technologies. Ensuring that regulatory strategies are developed early in the the device development process can provide a strategic advantage towards medical device approval. Pleiad's regulatory staff have the expertise to support your medical device from design concept to market approval.

  • United States: FDA

    • Investigation Device Exemption (IDE)

      • Pre-IDE Meetings

      • IDE submission

      • IDE management (Annual Reports and Supplements)

    • Premarket Notifications 510(k)

    • PMA support

    • US Agent for Foreign Establishments

  • Canada:

    • Investigational Testing Authorization (ITA)

      • Pre-application Meetings

      • ITA submission

      • ITA management (Annual Reports and Supplements)

    • Device License Application

  • EU:

    • Assembling technical files or design dossier

    • Ensure essential requirements are met

    • Determine the required conformity assessment route based upon device classification

    • Identify any required harmonized standards

    • Evaluate clinical evaluation requirements

      • Clinical Literature Reviews (Critical Clinical Evaluation)

    • Prepare Clinical Trial Applications for EU based clinical studies

    • Assist with Notified Body selection

    • Design and Development of Technical Documentation and Risk Management (ISO 14971.2007)

    • Quality system assessment against ISO 13485(2003) and MDD requirements

    • Develop post market clinical evaluation and vigilance strategies

    • Product packaging and labeling requirements

Regulatory Services - Medicinal Products

The path to medicinal product development can be long and complex. Successful market approval is dependant upon a sophisticated regulatory strategy that fits the unique product challenges that may be faced during development. Quality and timely regulatory documentation is essential in ensuring the achievement of drug development milestones. Effective communication with regulatory bodies early in the process is essential. Our experienced regulatory team can assist by providing strategic regulatory plans that integrate with your product development programs.

  • Regulatory strategy planning

  • Regulatory intelligence

  • Regulatory liaison

  • Clinical program development (protocol and investigator's brochure development)

  • Pre-application Meetings (Pre-IND, Pre-IMPD)

  • Clinical trial authorizations IND, IMPD and CTA

  • Orphan drug designation application

  • Drug master files

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