About us

EurekaReg is a provider of global regulatory affairs and product development solutions for the device, biotech and pharma industries. We are a New England based company serving all international medical markets eager to bring their products to commercialization.

Services

With a team of medical experts, EurekaReg develops custom product development programs for medical device, biologic, biotech and pharmaceutical products. Our services are comprehensive, yet customized, for immediate impact. These include:

Strategic and Development Solutions:
  • Global Regulatory Strategy
  • Product Development and Scale-Up Programs
  • GAP Analysis and Compliance services
  • US Agent Representation – for foreign clients
  • Staff Augmentation
  • Strategic sourcing and supply chain
  • Project Management
  • Validation and process engineering services
Regulatory Services:
  • Regulatory Submissions and documentation
           (IND, NDA,BLA, eCTD, 510(k),IDE, PMA) 
  • Vaccine and Biotech product development
  • CE Mark and International registrations
  • Design Control and Development
  • Product registration – Domestic and International
  • Risk Management and evaluation
  • FDA and Notified Body Liaison
  • Usability and Human Factors
Quality System and Compliance Solutions:
  • Quality Suite Development
          -- GMP, QSR, ISO 13485, ICH
  • Quality Systems implementation
  • Quality systems documentation
  • Internal and Supplier audits
  • Supply Chain Management
  • CAPA Management and Compliance
  • Equipment Validation and Qualification