EXPERIENCED LEADERSHIP, RAPID RESPONSE, AND EXACTLY MATCHED TALENT

Regulatory

Among the challenges of rising complexity and regulatory scrutiny, there are also opportunities. For life sciences companies that manage the complexity and meet the rigor to continue to deliver innovative pharmaceuticals and medical devices to the patients who need them, there is a tremendous opportunity to leapfrog competitors that get mired in the complexity and rigor. With regulatory leadership experience, rapid response, and exactly matched talent, The Evanston Group can help you do exactly that.

REGULATORY SUPPORT FOR NEW PRODUCT DEVELOPMENT & LIFECYCLE MANAGEMENT

Across hundreds of engagements, The Evanston Group has helped the largest and most sophisticated life sciences companies get their innovations to market – and keep them there.

In new product development, our consultants represent the regulatory function on clients’ internal cross-functional teams bringing new products through the development process – ensuring that those products will ultimately meet a regulatory pathway and get approved. When it comes time for submission, our consultants take the lead to ensure that the dossier can get approved by the regulatory agency, whether that’s the FDA or an international regulatory body.

On-market product changes might include changes in manufacturing, changes in material, a tech transfer to a different line, or any number of other changes to the product or how it’s manufactured. In lifecycle management, our consultants determine the criticality of the change and the resulting regulatory requirements – whether the change can simply go to annual reports or requires some other regulatory pathway to stay in compliance, and on the market.

DELIVERING VALUE ACROSS A WIDE RANGE OF REGULATORY ENGAGEMENTS

Global Drug Submissions & Approvals

‍IND, A/NDA, BLA, CBE, DMF Amendment, EMA

Global Device Submissions & Approvals

‍IDE, 510(k), PMA, CE Marking

Design Dossiers/Technical Files

Lifecycle Management

New Manufacturing Site Documentations and Submissions

Site & Documentation Audits

Licensing, Packaging, and Labeling Approvals

DRIVING PMA SUBMISSIONS FOR IVD MEDICAL DEVICE

Our consultant teams have led hundreds of successful submissions and approvals, including for new and niche products.

This $17 billion medical device company was facing an In Vitro Diagnostic Device (IVD) audit for pre-market approval (PMA) readiness and needed experts with particular experience in newer, higher-risk products. The Evanston Group provided a team of IVD regulatory and compliance experts with a history of successful IVD audits for PMA readiness to work on the client’s PMA submissions.

DEFINING REGULATORY PATHWAYS & WRITING MODULE 3 SUBMISSION DOSSIERS

Our CMC experts help clients successfully register alternate manufacturing facilities for on-market products.

When this $5 billion pharmaceutical firm was building out a new manufacturing facility in India, they came to The Evanston Group for help registering it as an alternate manufacturing site for on-market products. We brought in several regulatory consultants with experience in Chemistry, Manufacturing & Control (CMC) work. The team helped the client define the regulatory pathway and then wrote the Module 3 submission dossiers. The end result: The client registered the alternate facility and gained flexibility to manufacture on-market products in a new geography.

trusted by

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

Thank you! Your submission has been received!

Oops! Something went wrong while submitting the form.