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FDA Compliance for
Pharmaceutical Companies
Our FDA compliance service line enables you to get your products to market
quickly and to maintain your FDA compliance status. mdi has helped
hundreds of companies to achieve and maintain their FDA compliance. Below,
you will see a list of our specific service offerings. Please click on an
item below for more information.
PRODUCT LIFECYCLE
FDA Regulatory Strategic Planning
- What are mdi’s FDA Regulatory Strategic
Planning Services?
- Given that we understand the product development
process, the FDA submission process and the interplay between these
processes, we can craft a regulatory strategy based on your situation.
This strategy will include thinking through what actions you take,
what you document, what submission process to take, how to structure
your clinical trial, etc.
- How can mdi assist you?
- Many clients underestimate the economic value of a
carefully thought out FDA regulatory strategy. Because of our
experience and understanding of the FDA, through careful planning we
can help you to:
1. Minimize the time it takes to get through the
submission process, by correctly laying out the steps required and
preparing your submission appropriately
2. 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
3. Maximize your product revenues by enabling you
to sell your product while the FDA reviews your files
4. Optimize your competitive situation by thinking
through the how your submission type and structure will effect your
competitors, suppliers and customers
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Clinical Trial Management
- What are mdi’s Clinical Trial Management
Services?
- Our services include developing the clinical
protocol, setting up and interacting with the IRB (Institutional
Review Board), submitting the IND (Investigational New Drug),
recruiting and working with the investigator, monitoring the trials,
data gathering and analysis, project management, and statistical
analysis.
- How can mdi assist you?
- We work closely with the product's sponsor in
managing the clinical trials required for market approval. The study's
protocol would be based on the necessary requirements for obtaining
FDA's approval in the quickest and least expensive manner.
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ANDA/NDA/DMF Submissions
- What are mdi’s ANDA/NDA/DMF Submission
Services?
- An ANDA (Abbreviated New Drug Application) is a
required application that must be sent to the FDA in order to market a
product in the U.S. An ANDA must be submitted for the generic version
of the brand name drug providing the FDA how your generic version is
similar to the brand name drug.
- A NDA (New Drug Application) is a required
application that must be sent to the FDA in order to market a product
in the U.S. A NDA is required for all new drug products (never sold in
the US previously) that you want to market. The NDA application is
required to provide the FDA all the pre-clinical and clinical data
providing the safety and efficiency of the product as well as all the
manufacturing processes.
- A DMF (Drug Master File) is a file that is
submitted to the FDA that includes technical, clinical, and safety
information about an API (Active Pharmaceutical Ingredient). If you
are an API maker, your customers may desire a DMF from you. mdi guides
clients through the entire application preparation and submission
process.
- How can mdi assist you?
- Our staff has in-depth knowledge on how to submit
these applications and has developed strong relationships with the FDA
over the last 25 years. Given our experience, we can work with you to
successfully achieve approval for your submission whether you want us
to do it completely or for us to simply guide you through the process.
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FDA Quality System Strategy
- What are mdi’s FDA Quality System Strategy
Services?
- Assuring FDA compliance to quality system
requirements is critical for all pharmaceutical companies. The quality
system requirements are defined by 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,validations ) in order to get
in compliance quickly.
- How can mdi 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.
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Quality System Implementation
- What are mdi’s Quality System Implementation
Services?
- There are 5 key elements to a quality system:
quality manual, quality procedures, work instructions, product quality
plans and production level quality records. We can help you prepare
and implement the entire system for FDA cGMP (Current Good
Manufacturing Practices) compliance.
- We can supply you with a high-quality fully FDA
compliant quality manual and procedures that can be customized and
implemented for your operation. Our solutions include everything from
management review, corrective action/preventive action (CAPA) and
complaint handling. The manuals and procedures are easy to read,
follow and implement with the necessary procedures and forms. We can
implement them both electronically and paper-based.
- Since work instructions, product quality plans and
production-level quality records are completely unique to each
company, we can work with you to ensure that you are FDA compliant.
- How can mdi assist you?
- mdi has been
implementing Quality Systems since 1978, and has set up over 350
companies worldwide. We can guarantee that the quality system will meet
with all the FDA requirements. The systems have been continuously
inspected by the FDA and have passed each and every audit for compliance
to the cGMPs.
- If you are looking to sell product to the European
Community, or want the world recognized standard for quality, we can
also provide you assistance in meeting and implementing the ISO
9001:2000 standard.
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cGMP Audits
- What are mdi’s cGMP Audit Services?
- We can perform a mock FDA audit of your operations
to determine compliance to the FDA cGMP (Current Good Manufacturing
Practices).
- The audit would be performed in similar manner to a
FDA audit and can be performed by former US FDA field investigators.
- These mock audits serve two purposes: testing your
quality system and providing recommendations for corrective actions.
- How can mdi assist you?
- Given that we have been officially recognized as
experts by the FDA, we can provide you an audit that is the same as
what you can expect from the FDA.
- We have audited hundreds of the companies and
helped them to go through a real FDA audit successfully.
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Training
- What are mdi’s Training Services?
- We provide FDA cGMP employee training and internal
auditor training.
- Our in-house training sessions include all aspects
of FDA regulatory and quality system requirements including: cGMP
compliance, Process Validation, Sterilization Validation, FDA
strategic Planning, Dealing with FDA inspections and how to prepare
replies to FDA 483 and Warning Letters.
- How can mdi assist you?
- We can put together customized training programs
that are geared to your products and operations.
- We have trained thousands of employees over the
last 25 years.
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Validation
- What are mdi’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.
- Sterilization Validation - For contract
sterilization, we can review installation qualification documentation
from the vendor. For new sterilizers, we can perform installation,
qualification of equipment, testing, calibration and documentation. We
can prepare protocol for performance qualification and validate the
process by testing as per the protocol. We will then certify the process
with documentation accumulation, review and approval.
- Software Validation - Our software validation
assistance includes: validation protocol preparation; hazard analysis;
FMEA; and review. mdi's staff will work closely with your staff to
evaluate your validation requirements and present a full program and
milestone chart for assuring your software validation is completed
within schedule frame time.
- How can mdi 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)
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Stability Testing and Expiration Dating
- What are mdi’s Stability Testing and Expiration
Dating Services?
- We design stability testing programs that are fully
compliant with current FDA and Harmonization Guidelines.
- We offer all aspects of stability data analysis,
including linear regression analysis, with 95% confidence level
analysis, to determine acceptable expiration dating for your firm's
pharmaceutical products.
- How can we assist you?
- Give us a call to put together a custom
stability testing program for you.
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FDA Liaison
- What are mdi’s FDA Liaison Services?
- An FDA inspection could be one of the most trying
times in dealing with the FDA. Knowing what to expect, trying to
interpret the FDA findings and providing immediate solutions to
prevent regulatory actions could be critical to the survival of a
company.
- We provide ongoing support that allows you to
interact with our experts throughout the year. With this service, when
a FDA event occurs or a question arises, we are available to help you.
- How can mdi assist you?
- mdi's staff has successful navigated numerous
companies through FDA inspections both domestically and
internationally where the consequences of an actionable inspection
could prevent product commercialization.
- Our staff of former US FDA field investigators,
with over 100 years of combined FDA regulatory experience, provides a
professional demeanor to the FDA visit and assists to expedite the
inspection in a manner that has been proven over time.
- Our regulatory experience in dealing with the FDA
is unsurpassed, with successful removals of injunctions, seizures and
warning letters. Please see what our clients have had to say about our
services during an audit.
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U.S. Agent (for non-U.S. companies)
- What are mdi’s U.S. Agent Services?
- Non-U.S. medical device manufacturers must have a
U.S. Agent that represents them in the U.S.
- Our U.S. agent offering provides the following
services: Establishment Registration, Device Listing updates, Medical
Device Reporting, 510(k) Submissions and Official correspondent.
- How can mdi assist you?
- mdi is a U.S. Agent for foreign medical device
manufacturers in accordance with the US FDA regulations.
- For more information on this offering, please visit
our special website at
http://www.fdadesignatedagent.com
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