Author: Brandon Miller

Brownfield vs. Greenfield Facilities: Key Considerations for Onshoring Manufacturing

Posted on by Brandon Miller

brownfield greenfield

The global pandemic and continued supply chain disruptions have prompted many U.S. pharmaceutical and medical device manufacturers to reassess their reliance on offshore production. As organizations place greater emphasis on quality assurance, regulatory compliance, and supply chain resilience, onshoring manufacturing has become a strategic priority. Bringing operations back to the United States allows companies to strengthen oversight, enhance manufacturing reliability, and establish greater control over GMP processes.

 

One of the most important early decisions in this process is choosing between a brownfield facility or a greenfield manufacturing site. This choice influences implementation timelines, operational efficiency, regulatory readiness, and long-term scalability.

 

What Is a Brownfield Facility?

 

A brownfield manufacturing facility is an existing structure that can be repurposed to support new or expanded operations. Companies may lease or purchase the facility and complete the modifications required to support production. In many cases, the site already includes established utilities, cleanroom environments, operational workflows, and experienced personnel.

 

Some organizations may even have suitable brownfield options within their own corporate network. During evaluation, many rely on GMP facility design review to ensure the site meets modern standards.

 

Advantages of Brownfield Sites

 

Brownfield facilities are often preferred for their speed and efficiency. Since construction is not required, manufacturers can begin operations much sooner. This shortens transition timelines, reduces downtime, and supports faster technology transfer. Existing quality systems such as QMS, ERP platforms, CAPA management systems, and electronic documentation tools can also be integrated into the new operational framework. Organizations often turn to quality management system optimization to ensure alignment.

 

Challenges of Brownfield Sites

 

Older buildings may have structural or layout limitations that restrict scalability. Aging equipment may introduce inefficiencies or require significant upgrades to meet current expectations under FDA and EU guidance. Before transitioning, manufacturers should assess the site’s validation status and consider FDA inspection readiness services to identify potential compliance gaps.

 

What Is a Greenfield Facility?

 

A greenfield manufacturing site involves constructing a new facility from the ground up. This approach gives pharmaceutical and medical device companies complete freedom to design a building aligned with modern GMP compliance standards and advanced technologies.

 

Greenfield sites also allow companies to incorporate optimized cleanroom layouts and contamination control strategies that support sterile manufacturing and are consistent with EU Annex 1–style risk management.

 

Advantages of Greenfield Sites

 

A new build allows manufacturers to design workflows that reduce contamination risk, integrate advanced utilities, and install state-of-the-art equipment. A greenfield project also enables scalable infrastructure planning for future growth and long-term efficiency. Many companies leverage regulatory compliance support early in the design phase to ensure alignment with FDA and global expectations.

 

Challenges of Greenfield Sites

 

Greenfield facilities have longer timelines, higher upfront costs, and expanded staffing requirements. Construction delays, permitting schedules, and supply chain challenges can further extend project timelines. Organizations frequently use process validation support and technology transfer services to ensure smooth startup once the facility becomes operational.

 

Choosing the Right Onshoring Strategy

 

Selecting between a brownfield and a greenfield strategy requires a comprehensive assessment of:

  • The complexity of your manufacturing process
  • Speed-to-market requirements and timelines
  • Long-term capacity and scalability needs
  • Regulatory risk and inspection risk (FDA, global)
  • Maturity of your quality system and digital infrastructure
  • Total cost of ownership (capex, opex, validation)

 

Get Expert Support From Regulatory Compliance Associates®

 

Whether you are planning a brownfield retrofit or building a greenfield facility, establishing a strong compliance foundation from the very beginning is essential. Regulatory Compliance Associates® (RCA) delivers full-lifecycle support for life science companies, including:

  • GMP facility design reviews
  • Quality system implementation and remediation (QMS)
  • Inspection readiness and training, including mock FDA inspections, pre-inspection coaching, and audit preparation
  • Regulatory consulting for FDA submissions, global strategy, and agency communications
  • Process validation, technology transfer, and risk management to ensure robust, compliant operations
  • Supplier quality assurance to support stable raw materials and component sourcing

 

Partnering with RCA helps you align your onshoring strategy with regulatory needs, reduce compliance risk, and accelerate operational readiness. Our deep bench of industry and former-FDA experts will translate complex requirements into practical, actionable plans tailored to your organization.

 

Contact Regulatory Compliance Associates® today to connect with a subject matter expert and begin building a compliant, efficient, and future-ready manufacturing operation.

Compliance & Product Launch

Posted on by Brandon Miller

Why has product launch become more complex after the pandemic & how have the “roots of compliance” changed the EU regulatory environment?

 

 

In this sound bite from RCA Radio, host Brandon Miller is joined by Kinga Demetriou, an Expert Certifier at BSI, as they discuss how the pandemic changed the “roots of compliance” in the EU regulatory environment.

 

  • Since the pandemic, quick routes to market such as EUAs have been stopped leading to market servaliance company’s putting more scrutiny on products (e.g. PPE masks)
  • Manufactures have found out that offering a products in different markets take a lot of recourses to understand the roots of compliance depending on the location
  • Different market access requirement have been introduced depending on geography
  • New rules and certifications are in place making it more complex to launching products in multiple markets

 

Listen to the full Podcast on Global Regulatory Trends –> Click Here

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Addressing Troublesome Design Protocols

Posted on by Brandon Miller

What should you do if you are having trouble executing your design protocols? 

Listen to this highlight from RCA Radio where Walter Mason explains what needs to be done if you have troubles executing your design protocols even after training.

 

 

Listen to the entire episode where we take an in-depth look at protocols for biologics and their importance. RCA Radio Episode 13.

 

What can you do?

  • Go to the developer and let them know that it is not working for you
  • Talk through the design protocols in general
  • Procede step-by-step through the design protocols process
  • Look back at the FDA guidance documents
  • Get feedback on your design protocols
  • Implement changes in your training or to the protocol itself

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Medical Device Cybersecurity

Posted on by Brandon Miller

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates®, we offer a wide variety of services for medical device security to help ensure that your product is protected from cyber-attacks.

 

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Cybersecurity Medical Device Services

 

  • Supporting cybersecurity aspects of design control using secure design principles for the entire Product Lifecycle.
  • Performing Gap analyses on your device’s current cyber resilience.
  • Utilizing threat risk modeling to identify potential vulnerabilities or the absence of appropriate safeguards for future threats. 
  • Generation of regulatory submission documentation per the FDA’s cybersecurity guidance, as well as the EUMDR MDCG 2019-16 cybersecurity guidance.
  • Perform a cyber risk analysis to manage confidentiality, integrity, and availability and reduce attack surface area.
  • Create a software bill of material for purchased components of the product to better manage vulnerabilities.
  • Independent 3rd party validation of cybersecurity requirements.
  • Analysis and evaluation of current ISO 14971 risk management procedures.

 

Trustworthy Medical Device Cybersecurity

 

  • Contains hardware, software, and/or programmable logic that is based on FDA cybersecurity guidance and regulatory standards.
  • Provides a reasonable level of availability, reliability, and correct operation.
  • Is reasonably suited to performing its intended functions.
  • Adheres to generally accepted security procedures.

 

Cybersecurity Medical Device Best Practices

 

  • Identify assets, threats, and vulnerabilities.
  • Assess the impact of threats and vulnerabilities on the device’s safety and performance.
  • Assess the likelihood of a threat as well as the likelihood of a vulnerability being exploited.
  • Determine security risk levels and suitable mitigation strategies.
  • Evaluate residual security risk and risk acceptance criteria.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

How Brexit is Impacting Medical Device Companies

Posted on by Brandon Miller

Medical Device Regulations Changes coming with Brexit.

Listen to this highlight from RCA Radio where Seyed Khorashahi breaks down the UK’s Medical Device Regulations resulting from Brexit and choosing not to join the EU MDR.

 

 

Listen to the entire episode where we go over Brexit and all of the important things happening in the Medical Device industry here.

Looking for help adhering to the New Brexit Regulations? Contact Us Now →

Changes with Brexit

The UK will not be transitioning to the EU MDR or IVDR and will be staying with MDD, AIMD, and IVDD. They plan on making changes in the future as necessary for the UK market.

 

CE Marking

The MHRA will recognize the CE Mark for devices until June 30th, 2023. This applies to products CE marked under the

  • MDD, IVDD, AIMDD, and as well as MDR and IVDR.
  • Class I and General IVD manufacturers can continue to self declare.

 

Conformity Assessment Marking (UK CA)

  • UK Notified Bodies will become UK approved bodies starting January 1st, 2021
  • Device Manufactures can use UK approved bodies for UK CA marking starting on January 1st, 2021
  • UK CA marking will be mandatory on July 1st, 2023

 

MHRA Registration Requirement Dates

 

  • May 1st, 2021
    • Class III medical devices & IVD list A devices
    • Class II b implantable devices
  • September 1st, 2021
    • Class II b non-implantable and II a & IVD list b products
  • September 1st, 2022
    • Class I medical devices and general IVDs

 

UK Responsible Person

Manufactures without a presence in the UK will need a UK responsible person which can be an individual or company similar to EU authorized representative.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

 

In-Vitro Diagnostic Devices Regulation (IVDR)

Posted on by Brandon Miller

The application date of May 26, 2022, for the EU In-Vitro Diagnostic Medical Devices Regulation (2017/746) (IVDR) has created a huge challenge for IVD medical device firms planning to introduce or continue to market their IVD products to any of the European Union Member States. 

 

One of the biggest changes from IVDD to IVDR is the move from list-based IVD device classifications to a rule-based IVD medical device classification resulting in 4 new device classes: class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body involvement.

 

Need help with your transition to the EU IVDR? Contact Us Now →

 

“The combination of major changes to the IVDR device classification resulting in 3-fold increase in IVD medical devices requiring notified body involvement and lack of adequate IVDR designated notified bodies has created a huge bottle neck to getting ready for the EU IVDR by the application date of the EU IVDR.” says Seyed Khorashahi, Executive Vice President of Medical Device and CTO of Regulatory Compliance Associates Inc.® (“RCA”).

 

This change alone would result in a huge number of medical devices requiring Notified Body involvement. It is estimated this quantity of medical device products will increase from 20% under MDD to approximately 80% under IVDR.  As of this writing, there are only 4 IVDR designated Notified Bodies, which visibly increases the number of goods our clients must submit. 

 

 “Right now, we’re partnering with global clients that have both a small and sizable product portfolio of In-Vitro Diagnostic Devices, and they are at different stages in their IVDR implementation efforts,” says Lisa Michels, General Counsel for Regulatory Compliance Associates® Inc. (RCA). “Proactive strategic planning and effective resource allocation are critical for the timely execution and implementation of a comprehensive IVDR Implementation Plan. IVDR manufacturers must consider and prepare for potential delays such as scheduling bottlenecks for Notified Body Conformity Assessment activities, which may directly or indirectly impact their planned commercialization efforts for existing and/or new IVDR products. IVDR manufacturers must establish contingency plans to mitigate some of these potential challenges in this new regulatory environment under the EU IVDR since all IVDR manufacturers are facing the same task.”

 

Additional nuances from IVDD to IVDR are based on a medical device lifecycle approach and include:

 

  • Requirements for medical device manufacturers to establish and demonstrate effective quality management systems (QMS)
  • More stringent requirements for clinical evidence demonstrating conformity.
  • New requirements for post-market performance monitoring and reporting
  • Greater supply chain oversight and device traceability, including giving the notified bodies discretionary authority to supplier audits and subcontractor compliance.

 

The transition from IVDD to IVDR can be a time-consuming process, and many companies are still in the process of regulatory transition. 

 

“It’s time-sensitive because our clients are learning how to deal with their current notified body, and if they are still the correct partner to work with” continued Khorashahi. “We initially start with a strategic approach to plan their regulatory strategy of current IVD medical devices in the field and their IVDD certificate expiration date to prioritize the products that need immediate attention. “Each of the IVD medical devices has to be reclassified according to the new IVDR device classification rules.”

 

If you are a small to medium size company and have not already started your transition, now may be the opportune time to engage with a strategic partner like RCA to prepare for the IVDR deadline.

 

“Timely compliance to the IVDR requires a dedicated team of subject matter experts to properly implement and execute the compliance deliverables as laid out in your IVDR Implementation Plan” continued Michels. “These deliverables may require extensive updates to a manufacturer’s existing Quality Management System (QMS), technical documentation, and/or establishing or enhancing a manufacturer’s body of objective evidence of clinical performance validation with a defined blueprint to address the product lifecycle.”

 

Your organization has a better chance of a successful transition by engaging subject matter experts like RCA who have an intimate familiarity with the planning and implementation of IVDR.

 

“Our experts can help you identify the intended purpose and the inherent risks associate with your devices, determine the device classification, and help create technical documentation in compliance with IVD regulation 2017/746.:es” Khorashahi divulges.

 

More robust procedures for post-market surveillance and post-market performance follow up must be put in place to successfully transition.

 

“RCA has the subject matter expertise, experience, and dedicated resources available to assist our clients with the seemingly daunting task of ensuring timely IVDR compliance prior to the fast-approaching deadline. Our proven capability is what clients find to be of most value in the selection and utilization of a regulatory compliance consulting firm like RCA.” replied Michels.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].