Regulatory Partnership

EMPOWER’s Regulatory Partnership Service provides on-demand regulatory affairs expertise tailored to the needs of your company. By partnering with us, you secure not just services but a commitment to your company's regulatory success on a flexible contract basis.

The Value

Of Partnering with EMPOWER

  • Engage regulatory expertise as your projects require, without the need for full-time hires. This flexibility allows you to scale services up or down based on current needs.

  • Avoid the overhead costs associated with permanent staffing while receiving high-quality regulatory support.

  • Leverage EMPOWER's dedication to regulatory excellence, which supports your business's growth while promoting long-term sustainability and market success.

What’s Included?

  • Access to expert advice when you need it, helping you navigate complex regulatory issues without long-term commitment.

  • We handle the upkeep and renewal of your regulatory registrations, ensuring they remain compliant and are processed on time.

  • Assistance with the creation, review, and maintenance of essential regulatory documents, ensuring they are up-to-date and compliant.

    Our services can cover a range of needs, including conformity checklists (such as the General Safety and Performance Requirements Checklist and the Essential Principles Checklist), declarations of conformity, Investigational Device Exemption applications, and Post-Market Surveillance documentation, among others.

  • Management and support for all aspects of regulatory submissions, from pre-submission activities to post-submission follow-ups.

  • Rest easy knowing that annual registration renewal requirements are met.

  • Ongoing compliance support, including monitoring of regulatory changes and advice on how to adapt your processes and products.

    If applicable, we can also cover EUDAMED and GUDID maintenance.

  • Comprehensive support in reviewing and documenting changes for regulatory impact, preparing supportive documentation, and if necessary, communicating with regulatory agencies to facilitate the change.

Flexible Contracting Tailored to Your Business Needs

Pricing Structure

EMPOWER’s Regulatory Partnership Service is structured to provide you with the regulatory expertise you need, exactly when you need it, without the overhead of a full-time hire. Pricing is structured to meet your business needs. Simply choose from one of the following models:

  • Retainer Model: For ongoing regulatory support, consider the retainer model, which secures a set number of consulting hours each month at a preferential rate. This model provides predictable costs and assured availability of services.

  • Hourly Consulting: If your needs are less predictable, hourly consulting rates allow you to access EMPOWER’s services on a flexible basis. This option is ideal for specific needs or ad hoc advice.

  • Project-Based Pricing: For defined projects, EMPOWER offers project-based pricing. This provides a fixed cost for the project scope, giving you financial clarity from the outset.

  • Custom Packages: Don’t see a model that suits your business? We can develop a custom package that fits your specific regulatory requirements and budget considerations.

Get Started

To get started on a Regulatory Partnership with EMPOWER, fill out the following form and you will be contacted within 48 hours. We look forward to partnering with you!