MS Strategic Solutions, LLC

Moses & Singer, LLP recognizes that the traditional practice of law is changing.  Our clients want and need more diverse service offerings, alternative fee arrangements such as project pricing, as well as new holistic models for service delivery.  To meet our clients’ end to end business needs, Moses & Singer, LLP has founded MS Strategic Solutions, LLC, an innovative consulting company which expands our firm’s service offerings to provide diverse strategic and advisory services to traditional and digital healthcare and life sciences organizations, and beyond.  MS Strategic Solutions, LLC is comprised of elite subject matter practitioners with significant experience in assisting a variety of healthcare focused companies to manage and solve their strategic, operational and compliance challenges.  Our professionals bring outstanding, efficient, and cost-effective services to our clients.

Contact one of our professionals below who can address your consulting needs:

Linda A. Malek

F. Lisa Murtha

Jason E. Johnson

 

MS Strategic Solutions LLC is wholly-owned by Moses & Singer LLP. MS Strategic Solutions LLC is not a law firm and does not provide legal services to its clients. Clients of MS Strategic Solutions LLC are not clients of Moses & Singer LLP, unless they have separately entered into an attorney-client relationship with Moses & Singer LLP. MS Strategic Solutions LLC provides non-legal services to its clients and the protections of a client-lawyer relationship (including, client confidentiality and attorney-client privilege) do not attach to such non-legal services.

 

For more information please contact us.

Prior results do not guarantee a similar outcome.

Overview

Moses & Singer, LLP recognizes that the traditional practice of law is changing.  Our clients want and need more diverse service offerings, alternative fee arrangements such as project pricing, as well as new holistic models for service delivery.  To meet our clients’ end to end business needs, Moses & Singer, LLP has founded MS Strategic Solutions, LLC, an innovative consulting company which expands our firm’s service offerings to provide diverse strategic and advisory services to traditional and digital healthcare and life sciences organizations, and beyond.  MS Strategic Solutions, LLC is comprised of elite subject matter practitioners with significant experience in assisting a variety of healthcare focused companies to manage and solve their strategic, operational and compliance challenges.  Our professionals bring outstanding, efficient, and cost-effective services to our clients.

Contact one of our professionals below who can address your consulting needs:

Linda A. Malek

F. Lisa Murtha

Jason E. Johnson

 

MS Strategic Solutions LLC is wholly-owned by Moses & Singer LLP. MS Strategic Solutions LLC is not a law firm and does not provide legal services to its clients. Clients of MS Strategic Solutions LLC are not clients of Moses & Singer LLP, unless they have separately entered into an attorney-client relationship with Moses & Singer LLP. MS Strategic Solutions LLC provides non-legal services to its clients and the protections of a client-lawyer relationship (including, client confidentiality and attorney-client privilege) do not attach to such non-legal services.

 

Life Sciences

The cost and regulatory burdens of bringing healthcare products to market continue to rise. Strategic and cost-effective decision making are necessary for both start-up and established companies to remain nimble and competitive in this environment. MS Strategic Solutions professionals work with both emerging and mature life sciences organizations to deliver personalized assistance to support, transform and sustain their healthcare, research and medical devices operations around the globe.  Our service offerings to life sciences organizations include:

  • Emerging Company Start Up Advisory Services
  • Pipeline and Portfolio Review for Strategic Operational and Organizational Solutions
  • Contracting and Budget Support
  • Manufacturing and Distribution Logistics and Operations
  • Human Subject Protections/Informed Consent Development
  • Privacy and Cybersecurity Services
  • Advice related to Clinical Trial Management Systems Consulting
  • Work Force Regulatory Training
  • Strategic IP Portfolio Development
  • Pharmaceutical and Device Product Development Regulatory Services
    • Clinical Trial Design
    • Commercial Launch Strategies
    • GCP Assessment and Regulatory Services
    • 483/Warning Letter Remediation
    • Research Subcontracting / Site Selection & Management
    • Project Management
    • Drug Marketing Advisory Services
    • FDA Regulatory Consulting]
    • IND/IDE application
  • Healthcare Business Strategy Consulting
    • Strategic Partnership Development
    • Reimbursement Strategies
    • Commercial Growth, Partnership and Realignment Strategies 
    • Revenue Cycle Improvement Services

Research and Innovation

Research and innovation are essential to the successful advancement of healthcare solutions. However, the competitive research environment creates challenges for healthcare organizations in building a compliant research culture, while also creating effective processes to identify and support promising innovations to introduce to investment partners, or to the market. MS Strategic Solutions works with hospitals, universities, research institutes, and contract research organizations (CROs) and related organizations on regulatory and operational matters to solve these problems.  We assist these organizations in developing streamlined and more agile research and development processes to improve overall operations that support and foster a compliant, efficient and cost-effective scientific research culture.  Once the pipeline is in place, we help organizations build processes and platforms for identifying the right innovations and creating a more efficient research strategy. Our service offerings in this area include:

  • Grants Management
    • Effort Reporting Advice
    • Uniform Guidance Advice and Support
    • Federal Grant Audit Support
  • Responsible/Ethical Conduct of Research
    • Institutional Review Board Support
    • Conflicts of Interest Advice and Support
    • Researcher Misconduct Inquiry and Internal Investigation 
  • Research Operational Assistance (Clinical, Bench, Grants, etc.)
    • Assessment & Performance Improvement
    • Interim Management
    • Sponsored Project Oversight
    • Mock Audits/Assessments
    • FDA Regulatory Support
    • GMP, GCP Compliance Audits
  • Strategies to Develop, License and Market Innovations
    • Developing Business Strategy
    • Identifying Licensing, Joint Venture and Acquisition Opportunities
    • Support for In-house or Spin-off Product Development
    • IP Portfolio Development Strategies
    • Identifying  and Acquiring Investment

Compliance Support

Given the enforcement climate in the United States and internationally, regulatory compliance is an ongoing imperative.  Organizations must maintain effective compliance and privacy programs in order to meet government and customer expectations and to ensure ongoing regulatory compliance with laws, regulations and policies. MS Strategic Solutions employs some of the nation’s most experienced and well-known compliance professionals who work with our clients to monitor and improve regulatory and operational compliance.  Our compliance related service offerings include:

  • Compliance/Privacy Program
    • Effectiveness Reviews
    • Executive Search/Recruiting for Compliance Program Leaders
    • Policy Development
    • Infrastructure Design
    • Training
    • Monitoring and Assessment Services
    • Consulting Support During Government Investigations
    • Expert Witness Services
    • Revenue Cycle Consulting and Coding and Billing Consulting

Privacy and Cybersecurity Services

As the world becomes more digitally reliant, there has been increased scrutiny on the privacy and security of the information collected. More and more U.S. states as well as other countries are passing stringent and robust privacy and cybersecurity regimes.  In an increasingly connected environment, taking a global and best practices approach to privacy and cybersecurity is necessary to remain competitive.  MS Strategic Solutions has developed partnerships with established third party cybersecurity consulting professionals, combining our privacy experience with their technical cybersecurity expertise to collectively provide extensive HIPAA, GDPR, and state information privacy and security services.  Our professionals have already established a comprehensive privacy practice and with our partnership with outside cybersecurity consulting professionals, we can advise our clients on complex  IT Security related issues as well. Our privacy and cybersecurity consulting services include:

  • Privacy and Cybersecurity Compliance Services
  • Privacy Policy and Procedure Development and Assessment
  • Workforce Training
  • Privacy Program Assessment and Strategic Restructuring Services
  • Privacy Program Enhancement Services
  • Interim Privacy Officer Staffing
  • Development and Implementation of Third-party Risk Management Programs
  • Business Continuity Policies and Strategies
  • Cybersecurity Services
    • Cybersecurity Policy and Procedure Development and Assessment
    • Penetration Testing
    • Workforce Training
    • Security Program Risk Assessment Services
    • Recommendations Related to Security Program Enhancement
    • Advice Regarding Regulatory Requirements
    • Cybersecurity Breach Response and Reporting Program Review and Strategy Assessment

Digital Health

Digital health includes mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.  There are a variety of regulatory and operational challenges faced by digital health companies and MS Strategic Solutions is poised to work with clients to address these challenges.  Our service offerings for digital health companies include:

  • Privacy Advisory Services
  • Preparation of Compliance Related Policies and Procedures
  • Workforce Training
  • Regulatory Assessment Services
  • Performance Improvement/Operational Enhancement Services
  • Health Information Technology (HIT) Integration
  • Business Process Automation
  • EHR Advisory Services
  • Meaningful Use Audits
  • Revenue Cycle Automation Services

For more information please contact us.

Prior results do not guarantee a similar outcome.