Advantu Supports Biotech

When Manufacturing and Supplier Quality Process Improvement is performed for biotechnology or “biotech” companies – it is  critically important to get it right…the first time.

Advantu RA/QA expertise help you implement and advance your quality culture in biotech.

We provide the third-party objective analysis and corrective support you need – while you stay focused on getting products built and shipped on time.

No more surprises!  Whether Biotech or Medical Devices – keep the quality of your products consistent while delivering them on an extremely reliable schedule.

Manufacturing and supplier quality process improvement is the solution to your customer satisfaction challenges.

For Example:

One of our biotech clients wanted to add an Instrument to their GMP workflow for large scale manufacturing, but they didn’t have the knowledge or resources necessary to accomplish the task.

Gap Analysis

Our process quality expert recommended a gap analysis, which enabled us to review all their QMS (R&D/Manufacturing) procedures, documentation and processes. Afterwards, he worked with the client to produce a thorough risk-based implementation plan, with items listed by order of priority.

Corrective Actions

Our team went to work, implementing all the corrective actions, and the client was able to successfully add the instrument to their GMP workflow; additionally, all of their processes & procedures were updated for compliance with FDA and International Standards. This included ensuring the proper Verification of Effectiveness (VOE) step is part of the CAPA process.


Now they have everything in place so, if an FDA audit should occur they’ll be able to sail through with flying colors. Additionally, they have high confidence their product will exhibit world class quality because of their newly updated ‘best practices’ processes.

Value Added Benefits to Biotech Companies!

Manufacturing for Biotech

  • Complete Harmonization with R&D
  • CMO Vendor Agreements which Protect your company
  • Fully understand your Vendor’s financial analysis
  • Awareness of your Vendor’s Cybersecurity
  • Improve communications by closing Gaps associated with siloed organizations
  • Increase market share with higher quality products shipped on time

Supplier Quality for Biotech

  • Dramatically improved (consistent) parts quality
  • Reliable ‘on time’ parts & materials delivery
  • Avoid downtime with enhanced reviews and inspections – mapped to expectations
  • No Surprise Policy – mutually predetermined responses to common challenges

In the age of outsourcing, drug and device manufacturers depend on their suppliers for critical activities, making them vulnerable to potentially devastating quality issues.

Additionally, many biotech manufacturers continue to operate under the false assumption that by handing over duties to suppliers, so too go the responsibilities for maintaining regulatory compliance. This is wrong.

Although it is in a suppliers’ best interests to keep themselves to a high standard of quality to attract clients, the regulatory burden rests on the company receiving their products or service.

Manufacturing quality is equivalent to supplier quality, in that, it’s ultimately the responsibility of the originating drug and device manufacturer to meet FDA quality standards for their products. If you are working with a contract manufacturing organization then you know there are unexpected negative impacts to customer satisfaction, your company’s reputation and ultimately your market share – when things go wrong.

Monitoring and managing quality is extremely important when outsourcing anything that could potentially impact your product.

Highly Effective Gap Analysis

Want to know quickly if your Manufacturing and/or Supplier Quality Processes are 100% effective and fully compliant? Have Advantu conduct a Gap Analysis. Contact Us now!

We can reveal the blind spots and help you avoid a devastating problem tomorrow – by mitigating the hidden risks today.

We want to help bring your processes to best practice status – so you can enjoy increased confidence with your delivered products.


Because more and more companies are outsourcing their manufacturing operations, it’s becoming increasingly important for leaders to establish (and constantly improve) their quality management systems, in order to ensure harmonization across research and development and manufacturing so no quality gaps occur.

Supplier Quality

Because cost control is critical to corporate profitability, the FDA is placing an even greater emphasis on manufacturers to control activities and materials provided by their suppliers. Each organization is responsible to ensure their suppliers provide materials and services that are fit for purpose throughout the product lifecycle, from product development through commercial distribution. In fact, regulatory agencies are focusing on supplier management through risk-based quality controls and open communication between the procuring organization and supplier.

Why does this matter?

The FDA (and other international regulatory agencies) specify that the contracting organization is ultimately responsible for the quality of purchased material and that the contract facilities are considered an extension of the manufacturer’s own facility.

In order to ensure the highest product quality, Advantu promotes a risk-based approach to qualifying, managing and auditing third party providers.

Are you curious about the secret to long-term process improvement? Training! Training! Training!

It’s the best way to keep everyone informed and up to date on the latest regulations. Not only how things should be done, but why. 

Want to know if your Supplier Quality Process is up to speed?  Have Advantu perform an Audit!

  • ISO 13485 – Yearly Supplier Audit

Advantu’s FDA Process Experts are experienced at performing Manufacturing and Supplier Quality Process Improvement

Our Process

  • GAP Analysis
  • Improvement Path Report
  • Implementation of Corrective Actions
  • Confirmation of Desired Goals Successfully Achieved

Our team can perform a Gap Analysis to identify and recommend QMS Process improvement areas, prioritize the improvement areas and develop short term, intermediate term and long term plan to ensure your QMS processes are clear, easy to understand and address “Common Sense Compliance”.

Challenges teams face:

  • Lack of process knowledge
  • Inconsistency with documentation
  • Gaps in their QMS due to Silos within their Organization
  • Need to demonstrate equivalence with predicates
  • Not providing all of the expected testing
  • Lack of knowledge regarding differences between verification and validation
  • Underestimating risk management requirements
  • Incorrect formatting of required documentation
  • Incomplete or not-easy-to-understand QMS processes
  • Major disconnects between R&D and Contract Manufacturing 
  • Lack of thorough vendor/sub vendor agreements with Suppliers
  • Missing or incomplete Training Plan across the organization

Why Wait?

If you’re experiencing these quality challenges – we know you’re under a lot of stress.

Here’s the good news – our experts have been helping teams address and systematically resolve these issues for decades – we can help you overcome your challenges and transition into a highly productive organization, capable of delivering quality products (on time) on a consistent basis.

Contact us today!