Goode
Consulting International, Inc. has provided expert execution of regulatory,
compliance, validation, custom in-plant training, and staffing since 1993. Our work has a proven track record with the FDA
and with our customers. Our regulatory submissions are customized to provide
a high level of assurance that your product will receive approval for
domestic marketing and sale in as short a time as possible.
Product design
verification and process validation are scientifically executed, using experimental
design and statistical methods, to ensure that the process is
stable and repeatable, and the product reliably meets your customers’ requirements.
GCI's award-winning
instructors customize your in-plant training experience to your exact
specifications. Compliance is measurably enhanced when your staff
receives clear instruction from our highly skilled trainers.
Technical documentation and CAPA are our
compliance specialties. We have helped numerous companies resolve 483
/ Warning Letter / MDD Audit observations and provide proactive auditing and
correction services to prevent regulatory actions from occurring in the
first place.
Staffing
Validation
Education
Compliance
