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MLKC Consulting understands FDA Medical Device Regulations and possesses the experience needed to bring your product to market.
We can assist in the following:
We can help you to meet the standards established for FDA Medical
MLKC Consulting understands FDA Medical Device Regulations and possesses the experience needed to bring your product to market.
We can assist in the following:
We can help you to meet the standards established for FDA Medical Device Regulations along with ISO and Quality and Risk Management Systems.
Our services ensure your products meet federal standards. These consulting services may include ingredient assessment and label review to ensure appropriate categorization.
We are highly experienced in the Blood and Tissue industry (including Plasma. Birth Tissue and Stem Cells)
We can assist with product/ equipment validation; Supplier/ Testing laboratory assessments; On-site inspections to ensure facility compliance to all applicable regulations and standards
We can provide technical, regulatory consulting, and guidance services for the Pharmaceutical Industry- Including generic and new drug products, OTC, and monograph drugs.
Did your establishment receive a FDA 483 or Warning Letter?
MLKC has experience assisting in FDA 483 and Warning Letter responses for industries across the life science market, including: medical devices, dietary supplements, drugs, and biologics.
We can go one step further by assisting your facility in the prevention of future regula
Did your establishment receive a FDA 483 or Warning Letter?
MLKC has experience assisting in FDA 483 and Warning Letter responses for industries across the life science market, including: medical devices, dietary supplements, drugs, and biologics.
We can go one step further by assisting your facility in the prevention of future regulatory observations, warning letters, or sanctions by providing compliance training and performing mock inspections.
No one likes to think about Recalls. They can be time consuming and costly.
Our consulting activities might include:
Additionally, MLKC consulting can also help with process contro
No one likes to think about Recalls. They can be time consuming and costly.
Our consulting activities might include:
Additionally, MLKC consulting can also help with process controls or implementing preventive actions to prevent future recalls.
Training is a necessity for any organization to be successful; however it is a requirement in regulated facilities. Whether you need in depth training related to a CAPA or audit finding or just need some refresher training or annual trainings, MLKC consulting can deliver. We will develop impactful and educational training programs that
Training is a necessity for any organization to be successful; however it is a requirement in regulated facilities. Whether you need in depth training related to a CAPA or audit finding or just need some refresher training or annual trainings, MLKC consulting can deliver. We will develop impactful and educational training programs that provide all levels of an organization with the tools they need to make quality conscience and compliant decisions.
Trainings are available On-Site or Virtually.
Past trainings have included:
MLKC Consulting is highly qualified to provide expert advice on compliance, scientific, and technical matters. Our FDA Audit Services will allow your facility to take a proactive approach to quality assurance and regulatory compliance. These services will also allow you to accurately assess the activities and processes of current or fut
MLKC Consulting is highly qualified to provide expert advice on compliance, scientific, and technical matters. Our FDA Audit Services will allow your facility to take a proactive approach to quality assurance and regulatory compliance. These services will also allow you to accurately assess the activities and processes of current or future suppliers/ vendors.
Auditing services may include but are not limited to:
With over 30 years of experience in Quality, Helping organizations build or improve a quality system is on our veins.
These services may include :
With over 30 years of experience in Quality, Helping organizations build or improve a quality system is on our veins.
These services may include :
Our goal as consultants is to ensure your products can be manufactured and marketed using the safest and most cost-effective methods possible.
Being experienced experts in the FDA and other regulated industries allows MLKC Consulting to provide a full range of mission-critical services to the regulated industry. We will work with clients to design and implement effective and efficient business processes that will be sustainable.
By monitoring and tracking the ever-changing regu
Being experienced experts in the FDA and other regulated industries allows MLKC Consulting to provide a full range of mission-critical services to the regulated industry. We will work with clients to design and implement effective and efficient business processes that will be sustainable.
By monitoring and tracking the ever-changing regulatory environment and the regularly evolving industry practices we can help clients remain not only current but also compliant.
How and where you manufacture, store, distribute and sell products are equally important in efficacy, reliability and safety of the products in the supply chain. Therefore all these areas must meet specific licensing and registration requirements.
We can guide you through facility registration and product listings process.
These may include
How and where you manufacture, store, distribute and sell products are equally important in efficacy, reliability and safety of the products in the supply chain. Therefore all these areas must meet specific licensing and registration requirements.
We can guide you through facility registration and product listings process.
These may include:
Regulation of products doesn't start or stop with the manufacturer. All suppliers, contract manufacturers, distributors, testing labs, etc. must be willing and able to meet all the necessary requirements needed to ensure the product is effective, safe and reliable.
Whether you are manufacturer who needs to assess your suppliers and distri
Regulation of products doesn't start or stop with the manufacturer. All suppliers, contract manufacturers, distributors, testing labs, etc. must be willing and able to meet all the necessary requirements needed to ensure the product is effective, safe and reliable.
Whether you are manufacturer who needs to assess your suppliers and distributors or if you are a distributor of regulated products, MLKC Consulting can assist in the evaluation of processes and activities to ensure the applicable regulations and industry best practices and standards are being met.
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