FDA Medical Device Regulatory Planning
- MilkyWay Production's FDA Medical Device
Regulatory Planning Services:
- We understand the product development
process, the FDA regulatory process and the relationship of
these processes, We can create a regulatory strategy based on
your situation. This strategy will include actions you take,
what you document, what submission process to take, how to
structure your clinical trial, etc.
- How MilkyWay can assist you:
- Many underestimate the economic value of a
carefully thought out FDA regulatory strategy. Because of our
experience and understanding of the FDA, through planning we can
help you to:
- Minimize the time it takes to get
through the submission process, by correctly laying out
the steps required and preparing your submission
appropriately
- Minimize the cost spent in the
submission process by defining a specific roadmap that
allows you to identify the correct type of submission,
eliminate the typical clinical trial management mistakes
and reduce quality system implementation errors
- Maximize your product revenues by
enabling you to sell your product while the FDA reviews
your files
- Optimize your competitive situation
by thinking through how your submission type and
structure will effect your competitors, suppliers and
customers
FDA Quality System Strategy
- MilkyWay’s FDA Quality System Services:
- Assuring FDA compliance to quality system
requirements is critical for all medical companies. The quality
system requirements are defined by QSR (Quality System
Regulations) /cGMP (Current Good Manufacturing Practices)
guidelines which are specified by the FDA.
- The process by which to achieve compliance to
these requirements is different for each company. For example,
large companies may need to prioritize geographically-different
operations based on size/importance and implement systems
accordingly. A smaller company may need to prioritize which
elements of the quality system to implement first (e.g. work
instructions, design control) in order to get in compliance
quickly.
- How MilkyWay can assist you:
- Making these types of decisions requires
thought and planning because these decisions will affect the
speed and cost of the total implementation, potential savings
that could be realized through a quality system implementation
and the level of comfort the FDA will have that you are
implementing a compliant quality system.
Validation
- MilkyWay’s Validation Services:
- There are three types of validation
- Process Validation - We can assist in the
preparation of the validation protocol, implementing the
validation and interpreting the data to meet with the FDA
guidelines.
- Software Validation - Our software
validation assistance includes: validation protocol
preparation; hazard analysis; FMEA; and review. MilkyWay's
staff will work closely with your staff to evaluate your
validation requirements and present a full program and
milestone chart for ensuring your software validation is
completed within a scheduled timeframe.
- How MilkyWay can assist you:
- We can put together complete validation
protocols as well as execute the validations for you. Contact us
for more information on our validation services.
- Our services comply with the FDA’s Analytical
Method Validation (AMV) (including, linear regression analysis,
precision, accuracy, limit of detection, limit of
quantification, specificity and stability indicating
determinations) and Analytical Instrumentation Installation and
Operational Qualifications (IQ/OQ's)
|
