Attached files
| file | filename |
|---|---|
| 10-K/A - SensiVida Medical Technologies, Inc. | v210956_10ka.htm |
| EX-3.1 - SensiVida Medical Technologies, Inc. | v210956_ex3-1.htm |
| EX-10.7 - SensiVida Medical Technologies, Inc. | v210956_ex10-7.htm |
| EX-31.2 - SensiVida Medical Technologies, Inc. | v210956_ex31-2.htm |
| EX-32.1 - SensiVida Medical Technologies, Inc. | v210956_ex32-1.htm |
| EX-31.1 - SensiVida Medical Technologies, Inc. | v210956_ex31-1.htm |
| EX-10.16 - SensiVida Medical Technologies, Inc. | v210956_ex10-16.htm |
| EX-10.13 - SensiVida Medical Technologies, Inc. | v210956_ex10-13.htm |
| EX-10.14 - SensiVida Medical Technologies, Inc. | v210956_ex10-14.htm |
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163
Cabot Street
Beverly,
MA 01915
Phone:
(978) 927-3808
Fax:
(978) 927-1308
|
Agreement
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Client:
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SensiVida
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Date:
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May
21, 2010
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Project:
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Regulatory
Consulting: Assist SensiVida in developing an effective Quality System to
ensure compliance with FDA Quality System Regulations (QSR) and current
Good Manufacturing practices (cGMP). Conduct clinical trials and prepare
submission for SensiVida Microneedle Allergen Array Allergy
Test.
|
Project
Scope:
MDC is
prepared to assist SensiVida in developing a quality system to meet requirements
associated with FDA QSR and cGMP guideline. MDC will prepare a pre-IDE outlining
clinical study plans. FDA review of the pre-IDE will provide important guidance
on clinical study requirements. Based on FDA feedback, MDC will conduct clinical
trials, manage study data and prepare 510k submission for SensiVida Microneedle
Allergen Array Allergy Test.
Project
Overview:
MDC will
work with SensiVida on an as needed basis to accomplish the following
goals:
|
v
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Assist
SensiVida to develop and implement an effective design control process in
accordance with FDA 21CFR800. MDC will be available to assist
in assuring that all required design verification and validation data are
generated as needed for 510k review and clearance.
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v
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Assist
in developing design verification and validation
protocols
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v
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Define
design transfer requirements.
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v
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Assist
in selecting and auditing third party manufacturers, assuring that key
vendors are operating in accordance with FDA QSR and cGMP
guidelines
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v
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Establish
other quality system documents as needed during the initial phase of the
project
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v
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Develop
clinical and analytical study protocols
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v
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Develop
Labeling in accordance with FDA requirements
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v
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Prepare
a pre-IDE (early in the project) and submit to the pre-IDE to the
FDA.
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v
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Following
FDA review of the pre-IDE (usually about 60 days) schedule a meeting with
the FDA to discuss
requirements for the 510k submission.
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v
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Finalize
clinical and analytical study protocols based on FDA
feedback
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v
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Manage
the clinical trial, including selecting sites and assisting in the IRB
approval process
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v
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Collect
Study data
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v
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Monitor
study sites
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v
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Prepare
510k submission
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v
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Monitor
submission through the review and final clearance
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v
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Assist
in developing and implementing procedures for all elements of an effective
quality system
including:
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Management
responsibility and Review
Document
Control
Purchasing
Controls
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163
Cabot Street
Beverly,
MA 01915
Phone:
(978) 927-3808
Fax:
(978) 927-1308
|
Control
of Vendors
CAPA
Complaint
Handling
Environmental
Controls (as needed)
Inventory
Control (as needed)
Calibration
(as needed)
Process
control and validation
Project
milestones and timelines will be established during the initial phase of the
study.
Pre-IDE
will be a key milestone and should be able to be completed within 60- 90 days of
the start of the project.
SensiVida
development schedule will impact all timelines.
MDC
fee:
Monthly
Retainer: $7,900 per month for 16 months
SensiVida
can cancel this agreement at any time, but must provide MDC 30 days notice of
cancellation.
If
for any reason, the project is delayed, SensiVida can put the project on hold
and extend the length of the project.
SensiVida is responsible for all direct expenses
associated with travel and clinical study costs.
Agreed:
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By:
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|||
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/s/ Fran White
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/s/ Jose Mir
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Fran
White
MDC
Associates, LLC
President
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SensiVida Medical Technologies,
Inc.
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5/21/2010
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5/24/2010
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Date
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Date
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