Pharmaceutical, Medical Device, Biotech

Porzio delivers comprehensive support across pharmaceuticals, medical device, and biotech, guiding companies through intricate legal, regulatory, and compliance issues. Our counsel spans firm service lines and subsidiaries, fostering a holistic understanding of our client's businesses essential to fortifying their positions in competitive industries. By merging our proficiency in areas such as regulatory affairs, intellectual property, corporate governance, and litigation, we address immediate regulatory concerns and preempt potential challenges. We assist our clients on a full range of matters including: 

COMMERCIAL

Sales

• Field Personnel: Assisting in compliant management, education, and training of field personnel.
• Incentive Compensation: Advising on compensation plans to address compliance standards.
• Field Compliance Monitoring: Providing ongoing oversight of field personnel activity.

Marketing

• Promotional Materials: Creating policies and procedures for developing communications that meet regulatory and compliance standards. 
• Social Media Compliance: Providing guidance on compliant use of social media in marketing strategies, including the use of influencers, maintaining community guidelines, and reviewing space/character limitations. 

Market Access

• Price Transparency: Advising on compliance with transparency regulations and policies.
• Contracts: Drafting and advising on various market access and related agreements, such as distribution agreements, specialty pharmacy agreements, payor/PBM agreements, GPO agreements, and HUB/patient services agreements, including copay, PAP, and other program agreements, to address compliance issues and include favorable terms.

MEDICAL AFFAIRS

• Research Grants: Ensuring compliance in providing and obtaining research grants as well as compliance with contracts and agreements with investigators. 
• Promotional Materials: Creating policies and procedures for developing communications that meet regulatory and compliance standards. We regularly serve as legal reviewers on promotional and medical review committees. 
• Medical Science Liaisons (MSLs): Ensuring compliance with regulations and ethical standards, including developing governance policies for MSL interactions with healthcare professionals.
• Medical Communications: Offering counsel on strategies aligned with regulatory guidelines and assisting in the creation of compliant communication plans for interactions with healthcare professionals, key opinion leaders, and stakeholders.
• Investigational Drug Communications: Providing legal support for communications related to investigational drugs, ensuring adherence to regulations during the investigational phase through appropriate policies.
• Publications: Assisting in compliance with publication regulations, providing legal guidance on authorship agreements, copyright issues, and overall adherence to legal and regulatory standards.
• Educational Grants: Advising on compliance matters related to educational grants, ensuring grants are provided and used in accordance with regulatory standards.

CORPORATE

Corporate Communications

• Media Packages: Assisting in compliance with media-package regulations.
• Website Compliance: Providing legal guidance to align corporate websites with regulatory standards covering content, privacy policies, and terms of use to safeguard the company's interests.
• Social Media Compliance: Offering legal counsel for compliant corporate social media engagement including crafting policies, providing training, and conducting audits to mitigate risks and ensure ongoing adherence to legal standards.

Launch Activities

• Press Releases: Ensuring compliance in drug-launch press releases.
• Reviewing/Updating Policies and SOPs: Providing meticulous review and updates to existing policies and SOPs at various stages of company activities to comply with current laws, regulations, industry codes, and company policies.
• Training Programs: Designing, implementing, and conducting comprehensive training programs for involved stakeholders to help foster compliance and execute activities appropriately.
• Launch Materials Review: Offering legal guidance on launch materials, ensuring compliance with industry codes, and mitigating legal risks associated with marketing activities.
• Price Transparency Considerations: Advising on pricing strategies, regulations, and policies.
• Patient-Support Programs: Ensuring legal compliance in developing and implementing patient-support programs during launches, safeguarding both patient interests and the company’s compliance standing.
• Speaker Programs: Providing legal guidance on structuring compliant speaker programs, including contract assistance.
• Contracts: Assisting in drafting, reviewing, and negotiating launch-related contracts.
• Compliance Programs: Developing comprehensive compliance strategies for product launches, encompassing regulatory compliance, risk mitigation, and SOPs for adherence at every launch phase.
• Audits and Assessments: Conducting thorough audits and assessments throughout the launch process to verify compliance with regulatory guidelines, including proactive pre-launch audits to identify and address potential compliance gaps.

DISTRIBUTION

• Licensing Compliance: Ensuring compliance with state distribution licensing regulations. To learn more about our licensing capabilities, please visit Porzio’s Distribution Licensing website here. 
• Wholesaler Contracts: Drafting and reviewing contracts with wholesalers while ensuring regulatory compliance.
• Market Entry Contracts: Negotiating market entry contracts essential for successful market access, covering distributor relationships, exclusivity clauses, territory delineation, and compliance measures among other issues. 

HCPs

• Healthcare Provider Engagements: Assisting in regulatory compliance in engagements with healthcare providers, including drafting, reviewing, and negotiating contracts between life sciences companies and healthcare providers. We provide comprehensive legal support to facilitate compliant interactions, collaborations, and engagements while mitigating risks.
• Speaker Programs: Providing guidance on structuring compliant speaker programs, including contract assistance.
• Advisory Boards: Assisting in the establishment and management of healthcare advisory boards.
• Consulting and Publication Agreements: Drafting, reviewing, and negotiating agreements.
• Compliance Training: Designing and conducting compliance training programs for life sciences companies and healthcare providers. Porzio facilitates educational initiatives to ensure that clients are well-versed in regulatory requirements.

PATIENTS AND PATIENT ORGANIZATION INTERACTIONS

• Advocacy Plans: Developing compliant plans for patient advocacy to identify risk areas.
• Outreach Strategies: Guiding patient organizations on compliant approaches for patient outreach initiatives.

COMPLIANCE ASSESSMENTS, AUDITING, AND MONITORING 

• Compliance Programs: Developing comprehensive compliance programs to support successful company activities, including product commercialization. This involves creating detailed strategies encompassing regulatory compliance, risk mitigation, and standard operating procedures (SOPs) to ensure adherence to legal standards at every phase of the launch process.
• Compliance/Risk Assessments: Conducting thorough assessments throughout the launch process to verify compliance with regulatory guidelines, including pre-launch audits to identify potential compliance gaps, allowing for proactive resolution before the product launch.
• Privacy Compliance: Counseling on privacy considerations throughout the product and services life cycle, ensuring that life sciences companies adhere to applicable privacy regulations including guidance on handling personal information and sensitive data, structuring privacy protocols, and developing comprehensive strategies to satisfy and anticipate the growing matrix of applicable privacy laws and best practices.
• Business Rules and Training: Crafting business rules that align with legal standards and industry regulations, along with designing comprehensive training programs for employees and stakeholders.
• Investigations: Conducting investigations related to potential compliance breaches, ethical concerns, or other issues.

PREPARING FOR LAUNCH COMPLIANCE 

• Regulatory Guidance: Advising on regulatory requirements for conducting compliant clinical trials.

• Data Integrity: Ensuring data integrity and compliance with trial protocols.
• Compliance Oversight: Providing counsel on compliance considerations throughout the development process.

• Regulatory Alignment: Ensuring research activities comply with evolving regulatory standards.
• Grant Compliance: Advising on compliance requirements for obtaining research grants.
• Clinical Trial Compliance: Ensuring compliance with regulatory requirements in biotech-specific clinical trials.

COMMERCIALIZATION

• Market Entry Compliance: Guiding on compliance strategies for successful market entry.
• Distribution Compliance: Ensuring compliance in distribution channels for biotech products.
• Commercial Agreements & Promotion: Overseeing critical commercial agreements integral to the commercialization process, including distributor contracts, licensing, and collaborations. 
• Post-Market Oversight: Providing legal counsel for post-market surveillance and guiding companies in ensuring product safety and regulatory compliance, including assistance with adverse event reporting, product recalls, and other post-market compliance matters.