FDA expert sERVICES

Embarking on the adventure of FDA regulations can often feel like being thrown into a basket of sour lemons, but don’t worry — we're here to help you make sweet lemonade out of them! Our partner network of seasoned FDA investigators and regulatory compliance officers is ready to squeeze the stress away and guide you through every twist and turn.

At Citron, we specialize in helping companies like yours turn those regulatory challenges into opportunities, ensuring that your fantastic products not only meet the stringent standards of the FDA but also stand out as safe and effective options in the market.

Think of your Citron team as your zesty companions, serving as a GPS through the intricate and ever-evolving landscape of cosmetics, OTC, food/beverage, dietary supplements and health product regulations. 

With the guidance of the FDA's top former investigators by your side, we’ll make the journey from product development to market a refreshing breeze, guaranteeing compliance while turning potential pitfalls into stepping stones. 

Together, let’s transform your vision into a delightful and successful reality! Regulatory compliance simplified with Citron.
regulatory compliance
  • Mock Audit & Inspection Readiness: Preparing for FDA inspections and addressing any compliance issues that arise to ensure continuous adherence to regulatory standards.
  • Ongoing Compliance: Overseeing compliance with FDA regulations throughout the product lifecycle, from manufacturing practices to labeling requirements.
regulatory strategY development
  • Strategic Guidance: Advising on FDA requirements and crafting tailored strategies for product approval.
  • Regulatory Pathways: Offering expert guidance on selecting the appropriate regulatory pathways and submission types, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), and Premarket Notification 510(k) submissions.
  • Compliance Alignment: Ensuring that product development and submissions align with FDA guidelines and regulatory expectations.
PREMARKET SUBMISSIONS
  • Document Preparation: Assisting with the comprehensive preparation and submission of all required documents for FDA approval.
  • Submission Management: Managing various types of submissions, including INDs, NDAs, Abbreviated New Drug Applications (ANDAs), and Premarket Notifications for medical devices to ensure accuracy and completeness
clinical trial support
  • Trial Design and Conduct: Providing expert guidance on the design and execution of FDA-compliant clinical trials, including protocol development.
  • Regulatory Submissions: Managing submissions related to clinical trials and ensuring adherence to Good Clinical Practice (GCP) guidelines.
post market surveillance
  • Performance Monitoring: Monitoring product performance once it is on the market, including managing adverse event reporting and periodic safety updates.
  • Recall Management: Handling recalls and ensuring that necessary actions are taken to maintain product safety and compliance.
  • 483 and Warning Letter Responses: Addresses each observation, request clarification, and provide a timeline for correction to meet the FDA requirements.
Disclaimer: Partner Experts are independent and do not reflect any endorsement of one another. Become a partner.
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simplified fda compliance with citron.

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