FDA Regulatory & Compliance Services

At Sanchelima & Associates, we understand the complex regulatory landscape surrounding developing, manufacturing, and distributing FDA-regulated products. Our team of experienced attorneys deeply understands the policies that govern the FDA and its enforcement activities.

Failing to comply with FDA regulations can seriously affect businesses operating in FDA-regulated markets. The FDA can issue warning letters, seize products, and even refer cases to the Department of Justice for criminal prosecution.

Whether you’re a small start-up or a large corporation, we provide comprehensive FDA regulatory compliance services tailored to your needs. We aim to help you navigate the regulatory process efficiently and effectively, so you can focus on bringing safe and effective products to market.

FDA Registration Services

At Sanchelima & Associates, we provide comprehensive FDA registration services to help clients comply with FDA regulations and successfully register their products with the agency. We can assist with all aspects of FDA registration, including:

  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA) submissions
  • New Animal Drug Application (NADA) submissions
  • 510(k) Premarket notification submissions for medical devices
  • Food facility registration
  • Prior Notice submissions

We take a comprehensive approach to FDA compliance, and our goal is to help you successfully register your products with the agency while minimizing costs and reducing risk. Contact us today to learn more about our FDA regulatory compliance and registration services.

FDA Attorney Services in South Florida

Our team provides a wide range of services to help clients comply with FDA regulations, resolve compliance issues, and navigate this complex landscape.

Our services are designed to meet the specific needs of each client. We work closely with you to develop a tailored strategy that helps you achieve your regulatory goals efficiently and effectively. With our expert guidance, you can feel confident that your products meet all FDA requirements and that you’re prepared for regulatory challenges.

FDA Counseling

We’ll provide strategic counseling to help you comply with FDA regulations and avoid any compliance issues. Our team will work with you to perform regulatory compliance assessments, gap analysis, and risk assessments and develop a compliance program targeted to your needs.

At Sanchelima & Associates, we offer comprehensive FDA counseling services to guide a wide range of FDA-related issues, including:

  • Product development
  • Labeling and advertising regulations
  • Good Manufacturing Practices (GMPs)
  • Clinical trial design and management
  • FDA inspection readiness
  • FDA response strategies

Compliance Litigation

Even with the best intentions and comprehensive compliance programs, FDA-regulated companies may still be subject to FDA enforcement actions, warning letters, or other legal proceedings. When this happens, it’s critical to have experienced and knowledgeable FDA attorneys on your side to help you navigate FDA compliance litigations.

Our team provides comprehensive compliance litigation services, including:

  • Defending against FDA warning letters and other enforcement actions
  • Representing clients in FDA administrative proceedings, such as product seizures, injunctions, and consent decrees
  • Conducting internal investigations and audits to identify and remediate compliance issues
  • Litigating civil and criminal cases related to FDA violations

Regulatory Affairs

Our regulatory affairs team can assist with product development, regulatory submissions, and interactions with the FDA. We have experience working with various FDA-regulated products, including pharmaceuticals, medical devices, biologics, dietary supplements, and cosmetics.

At Sanchelima & Associates, we can provide comprehensive guidance on a wide range of regulatory affairs matters, including:

  • FDA product classification and registration requirements
  • Preparation and submission of FDA regulatory submissions, including INDs, NDAs, BLAs, ANDAs, and 510(k)s
  • Regulatory strategy development and implementation
  • Post-approval regulatory compliance, including annual reports, post-marketing studies, and labeling updates
  • Global regulatory affairs, including international regulatory requirements and harmonization efforts

Industries We Serve

Our team stays up-to-date on the latest FDA regulations and policies to ensure our clients comply with all applicable laws and regulations. We work closely with our clients to provide tailored solutions that meet their needs and help them achieve their regulatory goals.

Our multi-disciplinary team helps us assist clients in various industries:

  • Food and dietary supplements – we can assist with labeling and advertising regulations, good manufacturing practices (GMPs), and new dietary ingredients (NDI) notifications to ensure your products comply with all FDA regulations.
  • Cosmetics – we can help with regulatory compliance, including developing a plan for adverse event reporting.  

  • Pharmaceuticals – we have worked with many pharmaceutical companies to ensure their drug development, clinical trials, and advertising meet all FDA regulations.  

  • Medical devices – we can help you with premarket submissions, quality system regulations (QSRs), and adverse event reporting. 

Whether you’re a small start-up or a large corporation, our team can provide the expert guidance you need to navigate the complex world of FDA regulation.

Why Sanchelima & Associates

Working with an experienced FDA attorney can provide numerous advantages when it comes to navigating the complex regulatory landscape surrounding FDA-regulated products.

Expert Knowledge

Get access to our team of experts, who will operate as an extension of your team. We stay up-to-date on the latest developments in FDA regulation to ensure our clients comply with all applicable laws and regulations.

Risk Mitigation

FDA compliance issues can have serious consequences, including product recalls, warning letters, and legal action. Working with an experienced FDA attorney can mitigate your risk and avoid costly compliance issues.


Having an in-house legal team may not be cost-effective for you. At Sanchelima & Associates, our team becomes an extension of yours. Let us focus on your regulatory compliance, so you can continue focusing on your product development.

Personalized Attention

We take a personalized approach to our FDA regulatory compliance services, working closely with each client to develop a compliance execution plan that fits their needs and goals. 

Failing to comply with FDA regulations can break your business. Trust our team of experienced FDA attorneys to help you achieve regulatory compliance and avoid costly compliance issues. Contact us today to learn more about our FDA regulatory compliance services.

Sanchelima & Associates P.A.

235 SW Le Jeune Rd.
Miami, Florida 33134-1762
Phone: 305-447-1617
Fax: 305-445-8484
Email: info@sanchelima.com


Mon – Fri 9:30am – 6pm
Sat – Sun:  Closed

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