Services

Service Overview

We are a regulatory consulting company helping medical device and biotech companies on regulatory strategy development and regulatory filing of US FDA submissions. Regardless of where you are in the development or approval of your product, we can help. Our team consists of regulatory experts who have worked in FDA for many years. Experience makes a difference. We combine deep and broad scientific knowledge with extensive regulatory experience and effective communication for successful FDA approvals.

Regulatory Strategy

  • Advice on the identification of important regulatory elements to be addressed to market your product.
  • Provide consults on the alignment of regulatory activities and business strategy to bring a product to market.
  • Help to develop regulatory plans with specific steps and actions required to successfully meet the regulatory strategy objectives.

In vitro Diagnostics Device

  • Pre-submission preparation and FDA question formation to get agreement with the FDA on product development plan
  • Analytical study design
  • Clinical study design
  • Molecular diagnostic devices, Next generation sequencing based oncopanel, genetic tests, Direct-to-Consumer tests, Digital Pathology, Risk assessment tests, microbiological devices, immunological devices

Medical Device

  • Pre-Submission preparation
  • Study design
  • Regulatory submission strategy
  • Total product life cycle consulting

Companion Diagnostic Device (CDx)

  • Clinical study design for incorporating CDx in drug clinical trials (Phase I, II, III)
  • CDx product development plan in both analytical and clinical validation
  • Study risk determination request for drug clinical trial
  • CDx related study protocol writing, data analysis, clinical study report preparation

Quality Management System

  • Regulatory strategy and operations
  • Quality Management Systems Design
  • Identify regulatory documents required for PMA submissions

Digital Health

  • Advice on categorization of your digital health product for FDA regulated vs. not FDA regulated categories
  • Help to create the best strategic plan to meet regulatory requirements if your product is a FDA regulated medical device

Regulatory Submissions and Meetings

  • Pre-submission meeting request and submission preparation
  • Study Risk Determination
  • Breakthrough Device Designation request
  • Investigational Device Exemption (IDE) submissions and maintenance (original, supplement, amendment)
  • Pre Market Approval (PMA) submission 
  • De novo submission
  • 510(k) submission
  • 513(g) submission
  • EUA submission
  • Digital Health
  • FDA medical device meetings preparation
  • eSubmitter filing (eCopy policy compliance)