Craig Bleifer

LAWYER & CONSULTANT

 

Available For:

Business Counsel

Legal & Compliance Strategies

Outside General Counsel Services
 

Bar Admissions:

New York and New Jersey

Federal and State Courts

Noteworthy:
  • Former General Counsel to top-tier pharmaceutical companies

  • Awarded General Counsel of the Year

  • Awarded In-House Legal Department of the Year

  • Past Chair, PhRMA Law Section Executive Committee

  • Past Chair, Healthcare Institute of NJ (HINJ)

Education:

NYU School of Law - JD

Vassar College - BA, cum laude

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Craig Bleifer is an experienced General Counsel, Chief Legal Officer, Corporate Secretary, Board Member, Corporate Officer, and Executive Team member for top-tier pharmaceutical companies.  He has over 20 years’ experience in the US and Global healthcare industry and 28 years as an attorney.  He has been the leader of diverse corporate functions including Legal Affairs, Litigation, Compliance and Audit, Intellectual Property, Regulatory Affairs, Government Affairs & Policy, Communications and Corporate Social Responsibility functions.  He creates Legal and Compliance strategies for product development through regulatory submission and commercialization including product labeling, distribution, private/government contracting, advertising, sales and marketing strategies.  Craig is experienced in negotiating technology and product licenses, strategic alliances, co-development or commercialization agreements, acquisitions and divestitures of products, assets, facilities, or corporate entities.

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In addition to legal representation on distinct transactions or specific legal advisory matters, the Firm offers Outside General Counselservices providing a targeted and efficient way of outsourcing everything from routine legal tasks to legal portfolio management.

Outside General Counsel Services
 

Most businesses require legal support spanning many areas of legal expertise, such as commercial contracts, corporate governance, compliance, regulatory requirements and filings with multiple state or federal entities, employment matters, corporate transactions, intellectual property, litigation and others.  Critical legal issues are faced every day by companies, regardless of size, revenue, geography or whether the firm is new or “start-up”.  Often, the CEO, CFO or COO are left to manage legal issues, which is a distraction from their core duties.  It is difficult to have all of this expertise within an in-house legal function, yet companies would benefit from legal experts who can manage this portfolio of work.  Based on over 20 years’ experience as an in-house General Counsel and nearly 30 years of experience as a practicing attorney, the Firm can offer this same service, on an outsourced basis, serving as “Outside General Counsel” to companies that need this kind of legal management.

 

As Outside General Counsel, the Firm can customize our offerings and level of support to your organization’s needs and budget.  With a flexible and affordable cost structure based on an hourly, fixed fee or retainer basis, the Firm can serve as:

 

  • Legal Advisor – Legal advisor to the company, spotting potential legal issues,  crafting innovative legal strategies for business advantage, providing guidance to executives on compliance with laws and regulations, and how to anticipate pending or proposed changes to the relevant legal landscape based on legislative or administrative proposals at the state or federal level.

  • Representative / Project Manager – The Firm can “project manage” all or part of your portfolio of legal work, overseeing multiple outside counsel on your behalf and partnering with them for effective results.  This leaves company management to focus their time on managing the core business. 

  • Service Provider – The Firm can perform tasks often routinely sent to “big law” in a more efficient way.  The Firm can provide strategic, innovative approaches to execute, coordinate or oversee various types of legal work.

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AREAS OF FOCUS
 

Contract drafting, review and negotiation for vendors and third parties

Advertising and Promotion review

State/Federal regulatory reporting and other disclosure requirements

Legal and Compliance strategies for product development through regulatory submission, agency audit/inspection, manufacturing and commercialization including distribution, private/government contracting, sales and marketing strategies

Compliance Program Design, Training, Implementation

Employment Issues

Corporate Sustainability

Licenses and strategic agreements

Preparation of corporate governance documents, board and shareholder resolutions, directors meetings, shareholder meetings, and preparation of minutes

Counseling officers and directors on fiduciary duties

Internal Investigations & Remediation

Product Recall, Products Liability

Policy Development & Training

Risk Management, Crisis Management

Communications & Public Relations

Pharmaceutical / Healthcare Expertise

Advertising and Promotion review

PhRMA Code Compliance & Training

ANDA, Authorized Generics and Exclusivity Strategies

Products Liability analysis, strategy 

Sunshine and Transparency Reporting

HCP Consulting Agreements

Compliance Monitoring, Auditing, Remediation

GMPs, Inspections, Investigations, 483s, CAPAs and Recalls

CIA Negotiation, Implementation & Reporting

Risk Assessment & Management Process (“RAMP”)

DTC Advertising

Best Price, False Claims Act, Anti-Kickback Safe Harbors

CRO Agreements, IRBs, Informed Consent

Off-Label Marketing Issues

CMS, Government Reporting, Pricing

Grants, CME, Investigator Initiated Studies

NDAs, CRLs, Warning Letters, REMS, Label Negotiations

Market Access Strategies and Contracting with Payors, Wholesalers, Distributors

Medical Affairs Strategies, HEOR, Disease-State Messaging

Proprietary lobbying and advocacy initiatives

 
 
CONTACT

Craig Bleifer

LAWYER & CONSULTANT

Phone:

862-219-3138

 

Email:

craig@craigbleifer.com

© 2020 Craig B. Bleifer, LLC