Services

??????????????????????????????????????????????

At TheraGenesis, we are  P A S S I O N A T E  about advancing productive and fulfilling lives through innovation in medical technology!

Distinguishing Features:

  • Decades of clinical and regulatory experience in Europe and the United States.
  • Competence in the development of medical device and in-vitro diagnostic technologies, as well as pharmaceutical, biotechnologic, biologic therapies and nutritional products.
  • Broad spectrum experience in virtually all areas of medicine.
  • Geographic scope extending to all European countries.

DEVELOPMENT PLANNING - Strategy, Implementation, Success!

L I S T E N  to the customer!

Listening is frequently considered a passive skill. Partnership begins by actively listening for the customer’s  development objectives and re-creating these, bringing commitment, competencies and experience to bear, joining resources to realize these objectives. Herein, a variety of solutions appear.

  • Regulatory Affairs:
    • Technical dossier assessment for European clinical studies and CE Conformity Assessment,
    • Expertise and experience in communication with Competent Authorities throughout Europe,
    • Notified Body identification.
  • Clinical Affairs:
    • Your partner to answer the questions of what?, where?, who?, when?, why? and how much? surrounding your clinical development strategy,
    • Implementation of your clinical development plan.
  • Business Affairs:
    • You now have a CE-marked product: “Now what?” -OR- “So what?”
      • What is your plan to create clinical demand?
      • How will you get your product onto established patient treatment regimens?
      • Who will sell your product and serve your pan-european customers?
      • How will you quickly and reliably get your product to Lisbon and Helsinki and all points in-between?

CLINICAL STUDIES - Full Breath CRO Services!

P E R F O R M A N C E –  Generation of scientific and regulatory value!

Performance is a function of being an expert in the game; well-defining and focusing on the goals; bringing professionals to the team; providing the team what is needed; and communication, comunication, comunication…

Feasibility Assessment

  • Who are the clinical experts?
  • What is the body of clinical knowledge?
  • Where would your therapy best be received?
  • Where may potential study participants best be found?
  • What are the drivers of an optimal study protocol design?
  • What are the regulatory challenges and how best to address these?

Project Preparation

  • Bringing together a winning team of staff and investigators with the customer,
  • Optimize data capture, accuracy, validity, transparency,
  • Quality Systems dove-tailed to the project and our joint team structure,
  •  Successful navigation of the regulatory, institutional and ethical approval pathways.

Project Management, Initiation and Monitoring

  • Investigational site training, monitoring and management, quality, reliability and transparency in execution; teamwork; and regulatory compliance,
  • Commtment to the customer; project, budget and timeline transparency; and integrity in communication,
  • Communication with Competent Authorties with forefront commitment to regulatory compliance and vigilant attention to patient safety.

Project Completion

  • No loose ends!
  • Enabling study analysis, reporting and publication,
  • Ensuring regulatory closure.

AUTHORIZED REPRESENTATIVE - Fulfilling the Manufacturer's Regulatory Obligations

I N T E G R I T Y  – Providing Competent Authorities with confidence in regulatory compliance!

Non-european medical device manufacturers without a legal residence in the EU are required to identify their European Authorised Representative. Simply stated, through its’ Authorized Representative, european jurisdictional obligations are extended to the non-european manufacturer.

INTEGRITY  – doing what is expected, when and how it is expected out of the commitment to transparency, quality, reliability and partnership with the regulatory authorities. At its’ foundation, assuring patient safety and generation of trust and confidence.

Clinical Development Phase

  • Compliance with prerequisites for clinical investigations and performance testing,
  • Obtainment of clinical trial approvals from the respective Competent Authorities,
  • Adverse Event and Incident Reporting to the respective Competent Authority,
  • Importation of medical devices into the EU/EFTA,
  • Assurance of supply chain regulatory compliance and accountability of medical devices,
  • Maintenance of technical files for Competent Authority inspection.

Marketing Phase

  • Product notification to the Competent Authorities,
  • Product Safety Vigilance reporting,
  • Field Safety Corrective Action implementation, management, coordination and reporting,
  • Maintenance of technical files for Competent Authority inspection,
  • Communication with Competent Authority, Notified Body and distributors concerning regulated activities.