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.
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
2023 Trainings:
8/30/2023
12:00 – 1:30 pm EST
Medical Writing Fundamentals: How to Write Regulatory Documents
10/10/2023
9:30 – 11:00 am EST
Medical Writing Fundamentals: How to Write Regulatory Documents
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)
Pricing:
The Frestedt Learning Center (FLC) is proud to offer high quality training sessions. For example, the FLC offers courses generally priced as follows for each individual attendee:
-
1 hour course $200
-
1/2 day beginner course $500
(e.g., Clinical Evaluation Report Writing for Beginners; ICH E6(R1), ISO 14155: 2020, etc.)
-
1/2 day intermediate $800
(e.g., Clinical Evaluation Report Writing for Intermediate Level Learners, ICH E6(R1), ISO 14155: 2020, etc)
-
1/2 day hybrid (beginner to intermediate) $800
(e.g., Clinical Evaluation Report Writing course for Beginner to Intermediate Level Learners)
-
Full day (advanced) course $1200
(e.g., Clinical Evaluation Report Writing course for Advanced Level Learners)
FLC also offers customized training, volume discounts and full-service mentoring support for new employees as they learn about your internal operations.
In line with current learning approaches, the FLC also offers micro-learning formats if those are of interest. Please email the FLC at info@frestedt.com or call us at 612-219-9982.