YOUR SOLUTION PARTNER

You’ve got a challenge we’re ready to solve

Our vast network of trusted consultants have successfully completed thousands of engagements by providing high-caliber expertise, including program and project leadership.

PRODUCT, PROJECT AND PROCESS

Even the most successful companies know when to ask for assistance.

For decades, global pharmaceutical, medical device and other life sciences leaders have awarded the most demanding, complex assignments to us that result in critical decision-making and continuous mindset for innovation. We thrive on accelerating our partnership with you so you can achieve amazing things.

Our Horizontal capabilities

A few representative engagements:

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CAPABILITIES THAT DELIVER

Project Management Office

Project and Program management leaders with deep industry expertise and top talent to accelerate delivery of key initiatives from strategy to execution

Clinical

Clinical study managers, portfolio managers, lead CRA's, audit readiness consultants, biomarker and technical operations leaders, and study clinicians. Support for all therapeutic areas, from Discovery through Phase IV across Pharmaceuticals, Biologics, and Device studies.

Research & Development

Specialized cross-functional expertise across stage-gated product development, including Pharmaceuticals, Biologics, Combination Devices, and Medical Devices.  We support global R&D projects from Discovery through Lifecycle Management.

Quality Assurance & Control

Dedicated professionals to ensure Quality and Supplier systems process remediation: warning letter and consent decree prevention and remediation. Document control across design history files, device master records, drug master files, and labeling. CAPA and Adverse Events strategy and management.

Regulatory

Subject Matter Experts & Strategists specializing in specific approval pathway consulting for global submissions and approvals for drugs (IND, A/NDA, BLA, CBE, DMF Amendment, EMA) and devices (IDE, 510k, PMA, CE Marking Design).

Medical Affairs

Physicians, scientists, and medical monitors to drive global affairs strategy & operations, safety, communications, post-launch trials, Therapeutic Area (TA) and Disease specific support. Pharmacovigilance and Medical Safety, compliance operations, product launch and support. Key Opinion Leader (KOL) Facilitation and Management.

Mergers, Acquisitions, Divestitures, & Integrations

Change Management experts to support transformation, mergers, acquisitions, divestitures, integrations, and spin offs across business and technology. Master Data, records, and document management. Transitional Service Agreements (TSAs) and process/SOP integration & alignment.

Digital Transformation Strategy

Global Software Implementations (ERP, PLM, CRO, PPM), data management, and process re-engineering. Build next generation enterprise digital platforms leveraging Agile, UX design, product strategy and full stack development to advance your innovation agenda.

Supply Chain

Simplify the complexities of navigating conflicting priorities, lack of visibility, talent scarcity and outdated technology. Manage track and trace, serialization, and auditing/managing key suppliers.

Engineering / Manufacturing

Manage Site separation and relocation, supplier quality, raw material and API development, validation of new lines from CMO partners as well as CMC management, and product expansion and launch.

what our customers say

“Knowing how to match consultants with the industry knowledge who can jump right in, hit the ground running, and make it work for clients is why The Evanston Group is a top-notch organization from top to bottom.”
- Senior Project Manager and Clinical Researcher
“Placing hard to find, adaptable people with very specialized backgrounds and a working knowledge of projects that are more complex to run is how The Evanston Group differentiates from others in the market.”
- Clinical Manager specializing in rare disease
“My expectations were exceeded by the caliber of people The Evanston Group brings in. When I am looking for a special mix of talents, skills and background, The Evanston Group has been able to find and screen a very high quality set of resources. They are immediately right on target.”
- Senior Vice President, $10B medical devices company
“It is rare when a company and its associates can exemplify so many wonderful values with forethought and respect for those in their employ.”
- Software Engineer Consultant, Johnson & Johnson

Areas of Expertise

Clinical

Project leader expertise to support clinical phases 1–4 across trial design and execution; pipeline/portfolio management

Quality Assurance & Control 

Quality and supplier systems process remediation; warning letter and consent decree prevention and remediation

regulatory affairs

Regulatory SMEs & Strategists including specific approval pathway consulting for global submissions and approvals

Manufacturing & Engineering

Site separation and relocation, supply chain sourcing, raw material and API development, validation of new lines from CMO partners as well as product expansion, CMC management, launches

Supply Chain

The pharmaceutical and med device industry is navigating major upheaval. We connect the lab to the marketplace managing track and trace, serialization, and auditing/managing suppliers.

Mergers & Acquisitions

Strategy planning for mergers, separations, divestitures and transformations, including labeling changes, training and sales and reporter integration.

Research & Development

Innovative professionals that understand the crucial factors about the future of your company.

Product Management

The product vision with deep industry knowledge that will help you drive key initiatives.

Digital Transformation

Build next generation enterprise tools to solve problems and advance your innovation agenda.

MEDICAL DEVICE, REGULATORY

Medical Devices and Their Complex Regulatory Environments

A five-month remediation project saved a global device firm $200 million in recalls and penalties.
read case study

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