NorthStar Advisors

A life sciences legal and strategic consulting group.

NorthStar Advisors is a life sciences consulting firm specializing in compliant product launch and commercialization support, offering on-demand fractional general counsel and compliance officer services, PharmaLaunch™, our proprietary launch preparation strategy, and ad promo review process development and staffing for biotech and pharma organizations.

Why Choose Us                                                      

Our Expertise                              

  • Dedicated, highly experienced, cost-effective in-house general counsel services, proving ongoing legal support for your daily operational needs

  • Fractional chief compliance officers, compliance programs, and comprehensive and bespoke policy suites, training, and monitoring services

  • Our proprietary product launch and commercialization preparation strategy - streamlined, tailor-made, compliant review processes to ensure efficient and effective review and approval of product materials, messaging, and initiatives

  • Short- and long-term staffing support for pharma and biotech advertising and promotional review committees, including expert legal, medical, and regulatory representatives, and meeting coordinators

Introducing…

PharmaLaunch™

Under pressure and tight timelines to get your legal and regulatory processes and compliance program in place for PDUFA and launch?

Learn about our proprietary, streamlined strategy for cost-effective, customized, compliant product launch and commercialization.

ASK US HOW WE SAVED OUR BIOPHARMA CLIENT

$650K IN YEAR ONE.

     A beacon of light.    

Transforming the life sciences ad promo landscape, one success story at a time.

Organize your chaos.                                                       

We don’t simply navigate the challenges; we revolutionize the way forward-facing product materials and messaging are handled.

With our meticulously designed and expertly implemented processes, we ensure that your submissions meet the highest standards.

Ad promo review made simple.                                                

In the world of ad promo review, many companies find themselves trapped between subpar outcomes at best and utter chaos at worst.

Our secret?                                                                         

A set of guiding principles that serve as our North Star, leading the way to success. We craft a high-level action plan with concrete deliverables, including reduced meeting times, clear and streamlined processes, and enhanced team accountability.

At NorthStar, we’re not just problem solvers; we’re visionaries, transforming the ad promo review landscape one success story at a time.

Case Studies            

  • • As fractional general counsel of global biopharma company, implemented enhanced budget process, reducing spend by 38% YOY (budget: $1.5M), and enabling improved spend predictability and litigation strategies

    • Created and trained personnel on optimized, customized contract review process

    • Managed value-based relationships with outside counsel on litigation, IP, and HR issues

  • • Served as mid-size biotech company Chief Compliance Officer and Chair of Compliance Committee

    • Developed comprehensive Compliance Program consistent with HHS-OIG guidance

    • Implemented multi-phase roll out of suite of over 50 compliance policies, handbooks, SOPs, work instructions, memos, learning modules, and facilitated presentations critical to product commercialization

  • • Developed and implemented proprietary, streamlined review processes to ensure efficient and effective submission, review, and approval of ad promo and medical materials, messaging, and initiatives

    • Established and lead a cross-functional task force, conducted status quo assessment to determine optimal process mapping based upon company infrastructure and dynamics

    • Trained team members of all levels, including C-suite, department heads, reviewers, submitters, and agencies on optimized process

    Reduced meeting times by 55% and saved company ~$654,000 on ad promo review committee costs in year one

  • • Provided small pharma company with Legal, Medical, and Regulatory reviewers and meeting coordinator for autonomous product launch material review

    • Assisted company with vetting, selection, and implementation of electronic review platform and trained on system utilization

    • Provided comprehensive Introduction to US Regulatory Landscape training to key personnel

Reduce Your Legal Spend with Our General Counsel Services

By managing value-based relationships with outside counsel, we drastically reduce your legal spend

    38%   

Average client savings

   on legal fees   

Eliminate Wasted Manhours with Our Specialized Ad Promo Staffing Solutions

Our streamlined process suite and team of experts offering comprehensive support to help you efficiently navigate the complex regulatory environment.

   55%  

   Average reduction  

        in meeting time      

   40   

Manhours saved

per week on average

            Representative Therapeutic         

                     Area Expertise                   

Immunology ǀ Neurology ǀ Hematology ǀ Dermatology ǀ Analgesics ǀ Digestive Health ǀ Oncology ǀ CNS ǀ Allergy ǀ Cold and Cough ǀ Cardiovascular ǀ Pain Management ǀ Gastroenterology ǀ Critical Care ǀ Pulmonology ǀ Gene Therapy ǀ Women’s Health ǀ Rare Diseases ǀ Internal Medicine

           NorthStar Ad Promo         

            Thought Leadership           

4th PRC Performance Optimization Summit

Moderator, When “Keeping It Simple” Is Hard: The PRC Challenges of Patient-Focused Materials

June 2024
Philadelphia, PA

Fierce Promotional Review Committee West

Keynote Panel Moderator, Streamline MLR Operations Through Open Dialogue Across Functions

September 2022
San Diego, CA

Fierce Promotional Review Committee East

Presenter, Training New Marketers in Pharmaceutical Advertising

April 2022
New Brunswick, NJ

2019 Association of Corporate Counsel (ACC) Annual Meeting

Panelist, Practical Application of Design Thinking in the Legal Department

October 2019
Phoenix, AZ

Promotional Review Committee Compliance & Best Practices

Panelist, PRC Best Practices

September 2019
Morristown, NJ

Promotional Review Committee Compliance & Best Practices

Presenter, Organized Chaos: A PRC Survival Guide

October 2017
Florham Park, NJ

4th Annual Promotional Review Summit

Panelist, MLR/PRC Interactive Q&A Session

September 2023
Philadelphia, PA

Promotional Review Committee Compliance & Best Practices

Top-Rated Presenter, Characteristics of a Successful PRC Meeting

June 2014
San Diego, CA

8th Annual Porzio Life Sciences Compliance Forum, Seton Hall Law School

Panelist, Promotional Review Panel, Challenges and Ideas for Implementing Efficiencies in the Promotional Review Process

October 2013
Newark, NJ

Contact Us                                        

Interested in working together?

Fill out some info and we will be in touch shortly!

Schedule a Consultation                              

We are passionate about fostering a culture of compliance and collaboration, building strong working relationships based on trust and credibility, and empowering clients to compliantly achieve and exceed their business objectives.

Click here to schedule a consultation and get started.