and Consulting Services
for Biopharmaceutical and Pharmaceutical
Inc. provides a wide variety of services to help companies meet international regulatory challenges.
Consultants specialize in guiding small, start-up firms
to establish efficient, cost effective and quality systems,
will pass inspection and produce high quality products.
Recommendations related to
Regulatory Compliance strive to match the level of
client firm's stage in the Drug Development Process -
Pre-Clinical, Phase I through Phase III, up to and including
have varied expertise in all aspects of Quality, from writing SOPs, protocols and
Master Plans needed to set up a new manufacturing facility
to reviewing existing systems for compliance,
effectiveness and efficiency.
The pool of experts includes specialists in auditing
(including extensive international experience with a
practical knowledge of specific European regulatory requirements), process
validation, computer validation (including 21 CFR Part 11
compliance), equipment qualification, utility and
environmental monitoring, microbiology issues, and all
aspects of manufacturing.
GMP training seminars
in a wide variety of
topics, such as API GMP Compliance, Process Validation
Compliance for Biopharmaceuticals, and Electronic Records
and Signatures Compliance.
Courses can be presented on-site so that many personnel can
benefit from the knowledge, for the cost of sending one or
two people to an off-site event.
All ComplianceNet consultants come from biopharmaceutical
backgrounds and have worked successfully with many
traditional pharmaceutical and gene therapy clients. A
recent area of emphasis has been worldwide vaccine
If you have a
quality system that needs implementation
but are short on staff or experience, we can help you
start it or fully implement it.
If you are concerned about compliance at your contract
manufacturer, laboratory, or raw material supplier, we
can help you assess them.
you think now is too early to think about Process
Validation, think again. The more thought you
put into defining your product and process early on, the
more money and time you will save in getting to
market. Start now. We
can show you the critical things to consider to make
this complex project much easier.
If your existing quality system is too cumbersome and
labor intensive, we can provide alternative systems or
reengineer the system.
If you have validation
projects that need to be completed ASAP, we can jump in
and get it done.
have experience with dozens of Environmental
Monitoring programs and Utility
Monitoring programs. Let us show you what
works and why. Don't let these critical programs
be paper producing exercises. Turn them into
systems that will improve the quality of your product
and reduce later expenses for Investigations
and product rejects.
We can help you significantly reduce the time and
manpower required to complete your projects.
us today to discuss your needs.