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Our Services
| Vendor
Audits |
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| Not only are vendor audits/assessments imperative
for assuring quality product, vendor qualification is a top
focus in FDA now. ABC can develop a cost-effective and compliant
program for assuring vendor performance, as well as perform
the vendor auditing and qualification itself, all for less than
it costs to perform these tasks in-house. |
| Warning Letter
and 483 Responses |
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| Avoid costly and time consuming back and forth
with the agency due to insufficient commitments in the eyes
of FDA. Why hire a law firm to address this task, when ABC can
ensure a quick and comprehensive response to any 483 or Warning
Letter? Not only will our response save you time and money upfront,
ABC provides knowledgeable insight as to what the agency is
expecting to see in an adequate response to the issues presented. |
| Validation |
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| This is one of ABC’s core service offerings
and what we have become to be known for. Anyone can claim to
have hands-on knowledge about process validation, equipment
qualification, cleaning validation, and even computer system
validation. However, knowing how to write the test and execute
the test in order to prevent commonly encountered pitfalls is
the key to success. 25% of overall facility costs are associated
with validation activities. Don’t let the money you spend
become a wasteful effort. |
| CAPA Procedures |
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| Know how to correct an issue but still getting
cited for not having a solid preventive action? ABC can develop
a procedure for CAPA handling and help you to close out existing
CAPA investigations that meet regulatory expectations and are
sustainable within your organization. |
| Regulatory Agency
Submissions |
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| Got a 510(k), Structured Product Labeling (SPL) for Electronic Drug Listing, Drug Master File (DMF), Abbreviated New Drug Application (ANDA), State Department of Health (DOH) License, or other submission to FDA or a state agency? Let us get it submitted and through the regulatory hurdles faster, so you can concentrate on getting the product to market faster. |
| Due Diligence Assessments |
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| Don’t rely on the dog and pony show when
looking to purchase a company in the FDA regulated industry.
ABC can quickly get to the root of the company to assess both
compliance AND operational aspects of the organization to help
ensure that what you are paying for the company takes into account
the modifications to the operation that may be required. |
| Calibration and
Maintenance Programs |
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| Don’t have the funds to purchase and validate
a fully 21CFR Part 11 compliant calibration or maintenance software
package? We can help! We have help implemented numerous cost-effective
packages and even paper-based systems that have not only passed
regulatory inspection scrutiny, but that are also easily sustainable
for any organization. |
| Design Control
Programs |
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| Design control requirements are probably the most
misunderstood aspect of the medical device industry. We can
develop a simple program for you to follow or assess your existing
program to see if your interpretations of the requirements are
in compliance with what the agency currently expects. |
| SOP Generation |
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| Whether it be handling of out of specification
(OOS) results, operation and maintenance of your purified water
system, or handling customer complaints, ABC is single source
for generating standard operating procedures (SOPs) that are
accurate and customized for your company in order to both facilitate
training and to ensure consistent operations. |
| Contract Project
Management |
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| Need that project to come in on time and within
budget? Hire ABC’s project management services to get
it done. How good are our project managers? We have been hired
by clients on more than one occasion to manage projects being
executed onsite by other compliance consulting organizations!
ABC ensures that projects stay on track from beginning to end. |
| Training |
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| Looking to avoid paying for employee travel associated
with training/seminars? Looking to keep your cGMP training on
track annually as per regulatory expectations? Looking to keep
the topics current, applicable to your company’s operations,
and interesting for your employees? Then, ABC is your training
services provider. We do not charge per head or require that
your employees take days off to attend sessions out of state.
ABC comes to your facility and provides hands-on training on
many topics for as many of your employees that can fit in the
room for one flat fee. We customize every training sessions
to match your specific operations, and document the training
for you, so that full benefits are experienced from the sessions. |
| Label and Promotional
Material Review |
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| How can I say what I want to say on my product
labels and marketing materials without risking regulatory action?
Are product claims on our company website acceptable? These
are just a few of the questions ABC receives daily with regards
to label claims and marketing material compliance. We know how
you can get across your message without having to take all the
“meat” out of your marketing message. |
| Expert Witness
Services |
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| ABC’s expert witness services not only provide
technical expertise to your case, but we also are known for
being able to express confidence in direct testimony and under
cross-examination as well as being able to simplify complex
topics to get the point across quickly. |
| HACCP Programs |
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| If your company is in the seafood industry, then
you know about the Hazard Analysis and Critical Control Points
(HACCP) regulations. Let us develop a program for you that is
not only compliant but sustainable within your organization.
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| Mock FDA Inspections |
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| As one of our top requested services, our mock
FDA assessments (i.e. inspection readiness) are a great way
to initiate a project with ABC and get a top to bottom assessment
of where your organization stands from a compliance perspective.
Not only do we address every aspect of your operation, we also
provide a detailed report containing not only the observations,
but the risk-level associated with each observation. However,
that is not all! We also detail specific recommendations on
how to implement the most cost-effective corrective actions
for each and every observation noted. |
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