GLOBAL Regulatory Writing and Consulting
@globalrwc.bsky.social
We support Medtech and Biopharma innovators with strong, collaborative partnerships, tailored regulatory consulting and writing services, and deep strategic expertise.
Each year, the GLOBAL team comes together to support Salvation Army's Angel Tree Program. This is our 6th year participating, and the team came together to support gifts for 10 children. We are so appreciative to be in positions to give and support holiday cheer in our communities.
December 15, 2025 at 8:24 PM
Each year, the GLOBAL team comes together to support Salvation Army's Angel Tree Program. This is our 6th year participating, and the team came together to support gifts for 10 children. We are so appreciative to be in positions to give and support holiday cheer in our communities.
Our Medical Device team comprises leading experts with a track record of excellence. Contact us today to learn how our writing and consulting services can help you navigate your next submission with confidence. www.globalrwc.com/contact-us
December 4, 2025 at 6:35 PM
Our Medical Device team comprises leading experts with a track record of excellence. Contact us today to learn how our writing and consulting services can help you navigate your next submission with confidence. www.globalrwc.com/contact-us
At GLOBAL, we work with clients to complete projects with a high level of expertise and we train teams to manage this work ongoing. Check out this Case Study outlining how GLOBAL worked with a mid-size genetic testing firm seeking support implementing the new EU IVDR standards.
December 3, 2025 at 7:52 PM
At GLOBAL, we work with clients to complete projects with a high level of expertise and we train teams to manage this work ongoing. Check out this Case Study outlining how GLOBAL worked with a mid-size genetic testing firm seeking support implementing the new EU IVDR standards.
At GLOBAL, we support device manufacturers through every stage of the 510(k) process—from pre-submission strategy to final FDA clearance. Whether you need targeted writing assistance or end-to-end regulatory guidance, GLOBAL helps ensure your submission is accurate, compliant, and review ready.
December 2, 2025 at 4:48 PM
At GLOBAL, we support device manufacturers through every stage of the 510(k) process—from pre-submission strategy to final FDA clearance. Whether you need targeted writing assistance or end-to-end regulatory guidance, GLOBAL helps ensure your submission is accurate, compliant, and review ready.
We are thankful for another successful year and appreciate our partners, clients, and amazing team. We wish you all a happy Thanksgiving!
November 26, 2025 at 6:46 PM
We are thankful for another successful year and appreciate our partners, clients, and amazing team. We wish you all a happy Thanksgiving!
Under the older IVDD, only about 20% of IVDs required Notified Body review. Under the IVDR, that number jumps to nearly 80–90%, dramatically increasing the regulatory burden for most manufacturers. Let GLOBAL ease that burden by supporting your submission!
November 25, 2025 at 5:10 PM
Under the older IVDD, only about 20% of IVDs required Notified Body review. Under the IVDR, that number jumps to nearly 80–90%, dramatically increasing the regulatory burden for most manufacturers. Let GLOBAL ease that burden by supporting your submission!
Even experienced teams can encounter obstacles. Early planning and expert review are critical to avoid Refuse-to-Accept (RTA) or Additional Information (AI) letters, which can significantly delay clearance. Connect with us today to see how GLOBAL can help you avoid delays! www.globalrwc.com/contact
November 24, 2025 at 6:58 PM
Even experienced teams can encounter obstacles. Early planning and expert review are critical to avoid Refuse-to-Accept (RTA) or Additional Information (AI) letters, which can significantly delay clearance. Connect with us today to see how GLOBAL can help you avoid delays! www.globalrwc.com/contact
On this week's podcast episode, Violet Chazovachii - one of our medical writers - reflects on her attendance at RAPS Convergence 2025. She highlights sessions that stood out - one by Karen Jaffe, an MD with Parkinson's who discussed how to integrate patient advocacy into medical writing.
November 20, 2025 at 6:38 PM
On this week's podcast episode, Violet Chazovachii - one of our medical writers - reflects on her attendance at RAPS Convergence 2025. She highlights sessions that stood out - one by Karen Jaffe, an MD with Parkinson's who discussed how to integrate patient advocacy into medical writing.
This week we chatted with Violet Chazovachii about her experience at RAPS Convergence 2025 and she shared some amazing insights. Check out more on this week's podcast!
🔗 www.globalrwc.com/knowledge-center/podcasts
🔗 www.globalrwc.com/knowledge-center/podcasts
November 19, 2025 at 5:42 PM
This week we chatted with Violet Chazovachii about her experience at RAPS Convergence 2025 and she shared some amazing insights. Check out more on this week's podcast!
🔗 www.globalrwc.com/knowledge-center/podcasts
🔗 www.globalrwc.com/knowledge-center/podcasts
NEW EPISODE ALERT! On this episode of our podcast Chasing Compliance, we talk to Violet Chazovachii, Medical Writer at GLOBAL, and we discuss her experience at RAPS Convergence 2025. Check it out on all podcast platforms and share it with a colleague!
www.globalrwc.com/knowledge-center/podcasts
www.globalrwc.com/knowledge-center/podcasts
November 18, 2025 at 4:34 PM
NEW EPISODE ALERT! On this episode of our podcast Chasing Compliance, we talk to Violet Chazovachii, Medical Writer at GLOBAL, and we discuss her experience at RAPS Convergence 2025. Check it out on all podcast platforms and share it with a colleague!
www.globalrwc.com/knowledge-center/podcasts
www.globalrwc.com/knowledge-center/podcasts
For most medical devices marketed in the United States, the first step toward FDA clearance is the 510(k) premarket notification. Depending on the nature of the device and its modifications, manufacturers may submit one of several types of 510(k).
November 13, 2025 at 5:32 PM
For most medical devices marketed in the United States, the first step toward FDA clearance is the 510(k) premarket notification. Depending on the nature of the device and its modifications, manufacturers may submit one of several types of 510(k).
A successful 510(k) submission presents a clear, evidence-based argument that the new device is as safe and effective as its predicate. Typical components include the below; connect with GLOBAL to explore how we can support your team to a successful submission!
🔗 www.globalrwc.com/contact
🔗 www.globalrwc.com/contact
November 12, 2025 at 6:03 PM
A successful 510(k) submission presents a clear, evidence-based argument that the new device is as safe and effective as its predicate. Typical components include the below; connect with GLOBAL to explore how we can support your team to a successful submission!
🔗 www.globalrwc.com/contact
🔗 www.globalrwc.com/contact
For most medical devices marketed in the USA, the first step toward FDA clearance is the 510(k) premarket notification. This pathway allows manufacturers to demonstrate that their device is substantially equivalent to an existing legally marketed device in terms of safety and effectiveness.
November 11, 2025 at 5:23 PM
For most medical devices marketed in the USA, the first step toward FDA clearance is the 510(k) premarket notification. This pathway allows manufacturers to demonstrate that their device is substantially equivalent to an existing legally marketed device in terms of safety and effectiveness.
Our awesome management team for Medical Device Luke Baker, PhD and Beth Meier were in Minnesota this week connecting with our friends and colleagues local to the area.
November 7, 2025 at 5:34 PM
Our awesome management team for Medical Device Luke Baker, PhD and Beth Meier were in Minnesota this week connecting with our friends and colleagues local to the area.
Medical Device manufacturers often struggle with compliance challenges when working to meet IVDR requirements. Working with experienced regulatory partners can help identify documentation gaps early and maintain compliance continuity.
November 6, 2025 at 5:14 PM
Medical Device manufacturers often struggle with compliance challenges when working to meet IVDR requirements. Working with experienced regulatory partners can help identify documentation gaps early and maintain compliance continuity.
At GLOBAL, we help device manufacturers meet IVDR requirements efficiently and confidently. Our regulatory writers and consultants can:
- Prepare or update IVDR-compliant technical documentation and performance evaluation reports (PERs)
- Prepare or update IVDR-compliant technical documentation and performance evaluation reports (PERs)
November 5, 2025 at 8:00 PM
At GLOBAL, we help device manufacturers meet IVDR requirements efficiently and confidently. Our regulatory writers and consultants can:
- Prepare or update IVDR-compliant technical documentation and performance evaluation reports (PERs)
- Prepare or update IVDR-compliant technical documentation and performance evaluation reports (PERs)
The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) is the European Union’s regulatory framework governing in vitro diagnostic medical devices— tests and instruments used to examine human samples like blood or tissue.
November 4, 2025 at 4:42 PM
The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) is the European Union’s regulatory framework governing in vitro diagnostic medical devices— tests and instruments used to examine human samples like blood or tissue.
Our CMC team comprises leading experts with a track record of excellence. Contact us today to learn how our writing and consulting services can help you navigate your next submission with confidence.
www.globalrwc.com/contact-us
www.globalrwc.com/contact-us
October 30, 2025 at 4:10 PM
Our CMC team comprises leading experts with a track record of excellence. Contact us today to learn how our writing and consulting services can help you navigate your next submission with confidence.
www.globalrwc.com/contact-us
www.globalrwc.com/contact-us
Whether or not a sponsor is selected for the CDRP program, the lessons apply broadly: robust, regulator-ready CMC documentation is critical to success.
October 23, 2025 at 4:18 PM
Whether or not a sponsor is selected for the CDRP program, the lessons apply broadly: robust, regulator-ready CMC documentation is critical to success.
The FDA’s CMC Development and Readiness Pilot (CDRP) Program reflects a growing recognition that CMC is often the rate-limiting step in drug approvals—especially for expedited pathways. By engaging early and strategically, sponsors can reduce regulatory risk and accelerate the path to patients.
October 22, 2025 at 8:49 PM
The FDA’s CMC Development and Readiness Pilot (CDRP) Program reflects a growing recognition that CMC is often the rate-limiting step in drug approvals—especially for expedited pathways. By engaging early and strategically, sponsors can reduce regulatory risk and accelerate the path to patients.
In August 2023, the U.S. Food and Drug Administration (FDA) announced the launch of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program.
October 21, 2025 at 3:48 PM
In August 2023, the U.S. Food and Drug Administration (FDA) announced the launch of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program.
In recent years, cell and gene therapies (CGTs) have transformed from scientific breakthroughs into commercial realities. These advanced modalities are redefining how we approach rare, genetic, and otherwise untreatable diseases—offering patients options that were once unimaginable.
October 16, 2025 at 6:09 PM
In recent years, cell and gene therapies (CGTs) have transformed from scientific breakthroughs into commercial realities. These advanced modalities are redefining how we approach rare, genetic, and otherwise untreatable diseases—offering patients options that were once unimaginable.
Unlike traditional small molecules or biologics, CGTs bring unique complexities: individualized manufacturing, short shelf lives, and novel analytical methods. Regulators know this—and they place exceptional scrutiny on the CMC section of submissions.
October 15, 2025 at 5:29 PM
Unlike traditional small molecules or biologics, CGTs bring unique complexities: individualized manufacturing, short shelf lives, and novel analytical methods. Regulators know this—and they place exceptional scrutiny on the CMC section of submissions.
As the field of cell and gene therapy continues to evolve, developers face a critical decision early in product development. Check out this Case Study, where we compare a Fresh to a Cryopreserved cell therapy approach.
🔗 www.globalrwc.com/case-studies/cmc-case-study-4
🔗 www.globalrwc.com/case-studies/cmc-case-study-4
Fresh vs. Cryopreserved Autologous Cell Therapy Release Testing
A GLOBAL Case Study exploring the differences between release testing approaches.
www.globalrwc.com
October 14, 2025 at 8:09 PM
As the field of cell and gene therapy continues to evolve, developers face a critical decision early in product development. Check out this Case Study, where we compare a Fresh to a Cryopreserved cell therapy approach.
🔗 www.globalrwc.com/case-studies/cmc-case-study-4
🔗 www.globalrwc.com/case-studies/cmc-case-study-4
Bringing innovative therapies to U.S. patients involves navigating a complex regulatory landscape. Two of the most critical FDA approval pathways are the New Drug Application (NDA) and the Biologics License Application (BLA).
October 9, 2025 at 5:01 PM
Bringing innovative therapies to U.S. patients involves navigating a complex regulatory landscape. Two of the most critical FDA approval pathways are the New Drug Application (NDA) and the Biologics License Application (BLA).