PROVIDING THE MEDICAL / DENTAL / & VETERINARIAN - DEVICE INDUSTRIES WITH INNOVATIVE
CLINICAL & REGULATORY SERVICES
WELCOME TO NST CONSULTANTS, INC.
NST Consultants, Inc. was founded by Raymond Blanche after an extensive and varied career in the medical device industry that spans 40 years. During his career, he held positions in sales, marketing, product and business development, regulatory affairs, and technical and clinical education. This extensive background permitted him to segue into the field of clinical trial development and management along with related regulatory affairs that is “REAL WORLD” designed. This approach to solving the needs of its clients is based upon the fundamental concept that most start-up companies require a unique set of skills in its consultants, rather than the standard cookie cutter approach employed by the vast majority of clinical and regulatory specialists.
The objective of the client is the primary goal of any project accepted by NST Consultants, Inc. There are many methods that lead to failure, but the possibilities for achieving success are endless… it is this philosophy that steers our business model.
OUR TEAM
Raymond Blanche
Raymond founded NST Consultants in 1998, after an extensive and varied career in the medical device industry that spans 22 years. During his career, he held positions in sales, marketing, product and business development, regulatory affairs, and technical and clinical education. This extensive background permitted him to segue into the field of clinical trial development and management along with related regulatory affairs that is “REAL WORLD” designed. This approach to solving the needs of its clients is based upon the fundamental concept that most start-up companies require a unique set of skills in its consultants, rather than the standard cookie cutter approach employed by the vast majority of clinical and regulatory specialists.
Rebecca Settar, RN, BSN
Rebecca is a Registered Nurse and the Director of Clinical Services who works hands-on with the client to research, develop, organize and oversee all aspects of the clinical trial. She holds dual Bachelor of Science Degrees in Biology and Nursing and has over 15 years of clinical experience across acute and subacute platforms. Additionally, she is an internationally accomplished researcher, editor and author, capable of breaking down even the most complex concepts into manageable projects.
SERVICES
NST Consultants, Inc is ideally positioned to assist clients who require “Out of the Box” functional concepts and procedures for achievement of their business goals. The start-up company or entrepreneurial venture is a primary focus for this kind of project management approach. The objective of the client is the primary goal of any project accepted by NST Consultants, Inc. There are many methods that lead to failure, but the possibilities for achieving success are endless. It is this philosophy that steers our business model.
CLINICAL:
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Research and Development to Support RCT ( Randomized Controlled Trial)
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Clinical Trial Organization
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Investigator Selection
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Protocol Design and Construction
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Institutional Review Board Approval(s)
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Physician Management from a Performance and Risk Mitigation Standpoint
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Monitoring all Aspects of a Trial
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Assembly of other Resources and Individuals as Required – Engineering, Photography, Statistical Methods and Analyses
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Advance Notification of Device Design/Function Problems to Sponsor/Manufacturer by Organized Querying of End Users
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Literature Searches of Relevance
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Case Report Assembly
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Medical Writing Assistance and Guidance
REGULATORY:
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FDA Submissions – 510(k), IDE, PMA
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State, International Device Licenses
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Testing and Evaluation as Required for Submissions
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Prototyping for Testing
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Compliance Functions, Yearly Filings and Registrations
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Translation of Documents
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Import and Export Guidance
GENERAL SERVICES:
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Guidance on How to Avoid Common Pitfalls that can Lead to Legal Problems with the FDA , CBP and State Dept. of Health
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Providing Timely Feasibility Studies about Potential Device Development – Answering the Question- Is It a Device or Not?
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NST Consultants, Inc. Maintains a Very Limited Active Client Base – Ensuring Prompt Responses and the Highest Level of Performance
FEES
USA, FDA Registered Agent for Foreign Companies
Fee: $2,500.00 per year
Prior to Engaging a New Client, the Prospective Project is Pre-evaluated to Determine the True Level of Attainable Success.
One-time Fee: $2,750.00 ( will be applied to any project that is accepted)
FDA Labelling Requirements – GUDID – Registration
Fee: $3,000 – $6,000 per SKU. Yearly Maintenance Fee: Varies according to complexity. Fees: $1,500 and up.
All Accepted Projects are Proposed to the Client in a Format that Details the Project with a Global Fee, Payable in Installments: Some Examples are: 510(k) Submissions.
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Simple: Fee - $39,500
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Moderate: Fee - 49,500
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Complex: Fee - $69,500
Fees Cover all Labor, Office Expenses and Local Travel. The FDA Submission and Registration Fees are not Part of the Client and Project Global Fee.
Although it is not Possible to Quote a Precise Global Fee for Clinical Trial Projects, the Following Formula is very Indicative of Typical Costs.
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Simple Trial: Fee - $5,000 per subject
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Moderate Trial: Fee – $7,500 per subject
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Complex Trial: Fee – $10,000 per subject
For a Simple Trial with 20 Subjects, the Total Costs would be $100,000.00 Inclusive of all fees. Most Class I & II Devices Fall into this Category.
CONTACT US
nst CONSULTANTS, INC.
For a Complimentary Phone Consultation
Please Contact: Raymond R. Blanche
5 Cold Hill Rd. S, Unit 12C
Mendham, NJ 07945
Office: 973.531.6226
Mobile: 973.417.8675
Fax: 973.539.7445