7 Best Services to Help You Get FDA Approval in 2025 Review

Going through the complexity and red tape of FDA approval can be intimidating, with its ever-evolving regulatory guidelines and standards becoming more and more intricate.

Yet receiving FDA approval remains an integral milestone for medical devices, pharmaceuticals and other health innovations. But achieving it often requires meticulous planning and expert support. Luckily, there are services designed to ease this process and make sure companies can focus on innovation while meeting all required regulations.

In this blog, we will look at seven great ones you should consider in 2025, with each one complete with pros and cons to help make an informed decision regarding which solution would best suit your individual needs.

Table of Contents

1. Blue Goat Cyber

2. Greenlight Guru

3. RegDesk

4. Emergo by UL

5. Freyr Solutions

6. RAPS (Regulatory Affairs Professionals Society)

7. Veeva Systems

8. Conclusion

1. Blue Goat Cyber

Blue Goat Cyber stands out as a premier service for FDA approval, boasting an outstanding track record of 100% FDA clearance rates on client submissions. More than just testing vendors, Blue Goat acts as a trusted partner when it comes to regulatory affairs.

With services including secure product development frameworks (SPDFs), threat modeling, software bill of materials (SBOMs), penetration testing, cybersecurity risk assessments and postmarket monitoring.

These services meet FDA premarket and postmarket requirements such as Section 524B of the FD&C Act and ensure complete compliance during product deployment and secure product deployment.

• Pros: Proven 100% FDA clearance rate, extensive cybersecurity and risk assessment expertise, tailored premarket and postmarket solutions.  

• Cons: Services may be cost-prohibitive for smaller companies, entirely focused on cybersecurity and FDA-specific needs rather than broader regulatory scopes.  

2. Greenlight Guru

Greenlight Guru is an amazing quality management software tailored to medical device companies. The platform provides simple compliance with FDA and ISO regulations, making this an indispensable way to ensure your products meet all necessary standards.

Greenlight Guru helps businesses in maintaining an optimal level of efficiency while emphasizing innovation through streamlining processes like design control, risk management and documentation. This service stands out for its user-friendly design and comprehensive quality control features backed by responsive customer support.

However, its higher pricing may discourage smaller companies, while its functionality may only apply to medical devices, which might not meet all organizational requirements.

• Pros: Intuitive and user-friendly platform. robust quality control and compliance features, strong and reliable customer support.

• Cons: Higher pricing compared to competitors, limited to medical device industry applications.

3. RegDesk

RegDesk specialises in offering regulatory intelligence and submission services compliant with FDA guidelines, leveraging advanced AI technology to streamline review processes. AI-powered approach helps organisations speed review times while ensuring comprehensive compliance by providing real-world evidence and insights that enable companies to meet regulatory requirements effectively. RegDesk provides comprehensive services that aim to help businesses understand FDA regulations and speed up time-to-market solutions.

Though this platform provides cutting-edge tools and resources, its AI-powered regulatory systems may prove a bit confusing for newcomers to AI technology, presenting a steep learning curve. Also, the associated costs may become a big consideration for smaller organizations with tight budgets.

• Pros: AI-driven insights, comprehensive regulatory services, faster time-to-market assistance.  

• Cons: Steeper learning curve for beginners, costs can add up for smaller businesses.  

4. Emergo by UL  

Emergo by UL offers comprehensive consultancy and regulatory services tailored to assist companies with FDA submissions. Their experience extends from both pre-market submissions and post-market surveillance requirements, helping organizations meet these regulatory obligations efficiently. Emergo offers extensive resources, which enable it to streamline complex regulatory processes for its clients.

Clients benefit from tools designed to ease compliance and alleviate burdens related to FDA regulations. Emergo has earned itself a strong reputation within the industry for being a reliable partner when it comes to regulatory needs, yet their services may feel excessive for smaller businesses or startups with limited resources and simpler requirements.

• Pros: Highly trusted brand, extensive resources, FDA-specific expertise.  

• Cons: Service scope may feel unwieldy for startups, less tailored for smaller teams.  

5. Freyr Solutions

   
   

Freyr Solutions' comprehensive regulatory services aim to streamline FDA compliance across various industries, such as pharmaceuticals, biologics, medical devices and cosmetics.

Their experience managing detailed documentation and regulatory requirements helps clients save time while avoiding common compliance pitfalls. With end-to-end solutions available that cover every stage of the regulatory process from start to finish, though their pricing structure can differ depending on project scale and complexity which could present difficulties for smaller businesses with tight budgets.

• Pros: Broad industry coverage, deep FDA expertise, efficient documentation management.  

• Cons: High variability in pricing, potentially less accessible for startups.  

6. RAPS (Regulatory Affairs Professionals Society)

   
   

RAPS provides a range of regulatory training, resources, and consulting services tailored to help companies navigate FDA guidelines and requirements. RAPS offers education and support services designed to educate professionals navigating FDA reviews with changes anticipated in mind.

They possess a vast network of regulatory experts offering insights and expertise necessary for businesses to ensure compliance. RAPS emphasizes professional education and resource sharing to give industry members the tools and know-how necessary for success in today's regulatory landscape.

However, RAPS caters mainly to established industry professionals, not providing hands-on project management support that may be required by startups or small businesses looking for comprehensive assistance.

• Pros: Extensive educational resources, large network of expert professionals, reliable and thorough guidance.  

• Cons: Primarily caters to industry professionals, lacks hands-on project management tools.  

7. Veeva Systems  

   
   

Veeva Systems specialises in offering cloud-based solutions tailored explicitly for life sciences companies, focusing on compliance and FDA requirements. Their platform is designed to manage regulated content efficiently while streamlining approval processes and decreasing delays in compliance workflows.

Their advanced technology suits large organisations looking to maximise operational and regulatory efficiencies. However, its cloud-centric model may pose difficulties to smaller organizations with limited digital infrastructure who may struggle with fully utilizing its comprehensive tools.

• Pros: Sophisticated cloud-based technology, excellent for large organizations, enhances efficiency and streamlines compliance processes.  

• Cons: Cloud-based focus may not align with the needs of organizations with limited or outdated digital infrastructure.  

Conclusion 

Securing FDA approval requires patience, planning, and precision. These seven services aim to simplify the process, save time, and increase your odds of success. Each partner offers different strengths and limitations.

Choosing one depends on your organization's size, industry, and regulatory needs. Professional assistance allows businesses not only to achieve FDA compliance faster but also accelerate time-to-market and enhance product credibility.