The Attic Muse
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The Attic Muse

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Our Focus

We exist to help companies get consequential decisions right the first time.

We are engaged when the cost of being wrong is high.


Regulatory strategy, quality system design, market entry, and enterprise-scale programs require more than execution. They require judgment.


We focus on moments where clarity, timing, and alignment determine long-term outcomes. 


We say no to work that is purely transactional, and yes to work where experienced leadership materially changes the result.

What We Do

The Attic Muse is a principal-led consultancy founded in 2017 by Helen Kalorides who had the vision to bridge senior professionals with decades of experience building regulatory, quality, marketing, and commercial operations at Fortune 500 companies like Abbott, Roche, BD, and Freeman into a company that could actually deliver results, not make false promises.


After years of leading global regulatory affairs for Class III medical devices, managing $10M+ pharmaceutical exhibit programs, and building audit-ready quality systems from the ground up, our team saw a gap: many companies needed this level of expertise, but couldn't afford $300k+ executive salaries or the risk of hiring wrong.


So we built The Attic Muse differently.


We don't delegate. When you hire us, you work directly with former directors and leaders from private and Fortune 500 companies, not junior associates learning on your budget.


We don't overcommit. We only take projects where we can lead the execution personally. If we're not the right fit or don't have the bandwidth to give you the attention you deserve, we'll tell you upfront.


We don't just advise, we execute. We integrate into your business as embedded partners: on your systems, in your meetings, representing your brand. You get decades of operational expertise with the agility your business demands.


We don't publish client lists or case studies as our clients value discretion, and we value relationships built on trust. If you'd like to discuss our experience in your specific area, let's talk.

The Attic Muse Advantage

  • 35+ collective years leading global regulatory, quality, strategy, and marketing at companies such as Abbott Molecular, Sekisui Diagnostics, Roche, BD, and Freeman
     
  • Proven expertise in FDA submissions, all Classes Med Device & IVD
     
  • Comprehensive approach integrating regulatory &  strategy, operations, and marketing
     

Our value compounds through retained partnerships and refined decision frameworks.

How We Execute

Strategy & Operations

Tradeshows, Events, & Meetings

Regulatory Affairs & Quality

 

  • Strategic planning and organizational design
  • Policy formulation and process optimization
  • Customer relationship assessment
  • Competitor analysis and competitive positioning
  • Corporate assessment and resource development
  • Fractional executive leadership
  • SOP development and process mapping

Regulatory Affairs & Quality

Tradeshows, Events, & Meetings

Regulatory Affairs & Quality

 

  • Regulatory affairs strategy and submissions
  • Global registrations and market access
  • Quality systems implementation and improvement (ISO 13485, FDA QSR)
  • CAPA and compliance optimization
  • Medical software (SaMD) and cybersecurity
  • Design controls and documentation
  • Operational efficiency and audit readiness
  • Labeling and regulatory transformation
  • 510(k

 

  • Regulatory affairs strategy and submissions
  • Global registrations and market access
  • Quality systems implementation and improvement (ISO 13485, FDA QSR)
  • CAPA and compliance optimization
  • Medical software (SaMD) and cybersecurity
  • Design controls and documentation
  • Operational efficiency and audit readiness
  • Labeling and regulatory transformation
  • 510(k) and De Novo submission support
  • Risk management files (ISO 14971)

Marketing

Tradeshows, Events, & Meetings

Tradeshows, Events, & Meetings

 

  • Strategic advertising and brand positioning
  • Expert public relations and crisis management
  • Sales enablement and promotional strategy
  • Digital marketing and social media management
  • Impactful branding and creative direction
  • Content strategy and thought leadership
  • Graphic design and collateral development
  • Targeted regional marketing campaigns

Tradeshows, Events, & Meetings

Tradeshows, Events, & Meetings

Tradeshows, Events, & Meetings

 

  • Strategic program management and execution
  • Trade show and exhibit management
  • National and regional sales meetings
  • Corporate events and conferences
  • Sponsorship opportunities and activation
  • Planning, logistics, and organization
  • Enhanced customer experience and engagement
  • Comprehensive contract negotiations
  • Vendor management and budget optimization
  • HCP engagement with AdvaMed/PhRMA compliance

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