Our Services

 Frestedt Incorporated provides services for drugs, biologics and devices.
Alimentix provides services for foods, food ingredients and dietary supplements.
Frestedt Learning Center offers customized training events.

Frestedt Learning Center

Frestedt Incorporated offers both individual and group training on a wide-variety of topics relating to CRQE (clinical, regulatory, quality and engineering) functions.

Improve Efficiency with Individualized Training

Session length, content, group size and location are customizable. We offer remote and on-site training within the Frestedt 10-person conference room or at a client-selected location.

Conference room, person gesturing to slide on a screen, 2 people watch

We offer training to develop expertise in:

General Writing/Presentation

  • Technical Writing
  • Medical Writing
  • Publication Support
  • Presentation to Stakeholders

Quality

  • Good Clinical Practices
  • Good Documentation Practices
  • SOP design and implementation
  • ISO Standards

Preparing Clinical Documents

  • Clinical Trial Protocols
  • Clinical Trial Reports
  • Clinical Evaluation Plans and Reports
  • Periodic Safety Update Reports (PSUR)
  • Summaries of Safety and Clinical Effectiveness (SSCP)
  • Claim Substantiation Matrixes
  • Literature Reviews
  • Informed Consent Forms

Preparing Regulatory Documents

  • New Drug Applications
  • Investigational New Drug Applications
  • Pre-Market Authorizations (PMAs)
  • 510(k) Submissions
  • Investigational Device Exemptions
  • New Dietary Ingredient Applications
  • Generally Recognized as Safe (GRAS) Reports
  • Expert Panel Reports

Clinical Trial Activities

  • Planning, Initiation, Conduct, Close-out and Reporting
  • Submission to Regulatory Authorities
    (FDA and FTC)
  • Site Selection
  • Feasibility Assessment
  • Principle Investigator Services
  • Biostatistical Analysis
  • Objective/Endpoint Evaluation
  • Materials and Methods Appraisal
  • Personnel Training
  • Study Monitoring
  • Data Management
  • Safety Analysis
  • Dietary Analysis
Two people at a table, wearing face masks, one gesturing with hands, other writing on paper

Recent Trainings:

  • Technical Writing: Tips, Tricks and Ways to Improve
  • Good Clinical Practices (GCP)
  • Good Documentation Practices (GDP)
  • Generally Recognized as Safe (GRAS)
  • Transitioning to Medical Writing
  • European Union Medical Device Regulations
  • Clinical Evaluation Reports (CERs)
  • Writing CERs for Beginners
  • Medical Device Clinical Evaluations
  • Drug Development
  • Preparing Investigational New Drug (IND) Applications
  • Writing CERs Intermediate Training

Custom Training:

Please contact us to discuss developing a training to fit your needs! In addition to corporate training, we offer a variety of services and packages for individuals:

  • Initial Discussion (1 hour)
  • Retainer (1 hour for occasional quick emails, phone calls over one-month period)
  • Resume Critique/ Feedback (1 hour)
  • Quick Check-In for Specific Issue/ Advice (30 minutes)
  • Basic Career Transition Training (Three 1 hour sessions AND quick homework reviews)
  • Extended Career Management Program (8 session types including homework reviews)

Upcoming Trainings:

If you are interested in CER writing, consider joining us:

CER Writing MDD to MDR Transition

May 18, 2021, 8am-Noon

Beginner CER Writing Training

May 20, 2021, 8am-Noon

To request more information, please contact: dvanskike@frestedt.com