Pharmaceutical, Medical Device, Biotech

Porzio provides comprehensive support for pharmaceutical, medical device, and biotech companies, addressing intricate legal, regulatory, and compliance issues. Alongside our legal services, the consultants at Porzio Compliance Services (PorzioCS), a wholly-owned subsidiary, provide invaluable guidance and practical strategies for addressing compliance gaps and facilitating smooth operations while meeting regulatory requirements. By merging our proficiency in areas including healthcare compliance, regulatory affairs, corporate governance, and litigation, we help address immediate legal and 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 advice regarding field personnel activity.

Marketing

• Promotional Materials: Creating policies and procedures for developing communications that meet legal, regulatory, and compliance standards, as well as regularly serving as legal reviewers on promotional review committees. 
• 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 state price transparency regulations and related requirements.
• Contracts: Drafting, advising on and negotiating 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 patient support program agreements, to address legal and compliance matters.

Medical Affairs

• Research Grants: Reviewing and advising on research grant requests, including serving on grants review committees and preparing and reviewing agreements with investigators and research collaborators. 
• Medical Science Liaisons (MSLs): Counseling on compliance with laws, regulations and ethical standards, as well as advising on practices to help navigate appropriate separation from commercial divisions, including developing governance policies for MSL interactions with healthcare professionals and conducting related training.
• Medical Communications: Offering counsel on strategies aligned with legal and regulatory requirements and guidelines and assisting in the creation of compliant communication plans for interactions with healthcare professionals, key opinion leaders, and stakeholders, as well as regularly serving as legal reviewers on medical review committees.
• Investigational Product Communications: Providing legal support for communications related to investigational drugs and devices, guiding on adherence to regulations during the investigational phase, as well as compliant methods to disseminate pre-approval/pre-clearance communications.
• Publications: Advising on publication standards, and providing guidance on authorship agreements, copyright issues, and overall adherence to relevant legal requirements and industry guidelines.
• Educational Grants: Advising on compliance matters related to educational grants, including preparing/reviewing relevant policies, serving on grants review committees, and considering funding requests in accordance with legal, regulatory and industry standards.

Corporate

• Website Compliance: Providing legal guidance to help align corporate websites with legal, compliance and regulatory standards covering content, privacy policies, and terms of use to help 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 support ongoing adherence to legal and regulatory standards.
• Press Releases: Reviewing and advising on drug-launch press releases and other media related materials, including consideration of legal and regulatory requirements.

Launch Activities

• Reviewing/Updating and Drafting Policies and Standard Operating Procedures (SOPs): Drafting and providing review of and updates to existing policies and SOPs at various stages of company activities to comply with 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 guidance on launch materials for compliance with legal and regulatory requirements and industry codes, and mitigation of risk associated with marketing activities, including regularly serving as legal reviewers on promotional review committees.
• Price Transparency Considerations: Advising on pricing strategies, state price transparency laws and regulations, and related policies.
• Patient Support Programs: Guiding on legal compliance in developing and implementing patient support programs during launches, taking into consideration both patient interests and the company’s compliance standing.
• Speaker Programs: Providing legal guidance on structuring compliant speaker programs, including development of policies and business rules, contract assistance, and review of speaker program presentations and training materials.
• Contracts: Drafting, reviewing, and negotiating launch-related contracts, including contracts with advertising and PR agencies, HCP consultants, various marketing vendors, and publication support agencies.
• 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 help verify compliance with legal and regulatory requirements and related guidelines, including proactive pre-launch audits to identify and address potential compliance gaps.

Distribution

• Licensing Compliance: Navigating compliance with state distribution licensing laws and regulations. To learn more about our licensing capabilities, please visit here. 
• Wholesaler Contracts: Drafting and reviewing contracts with wholesalers in accordance with compliance requirements.
• Market Entry Contracts: Reviewing and negotiating market entry contracts essential for successful market access, addressing distributor relationships, exclusivity clauses, territory delineation, and compliance measures, among other areas. 

Healthcare Providers (HCPs)

• Healthcare Provider Engagements: Advising on engagements with healthcare providers, including drafting, reviewing, and negotiating contracts with healthcare providers and preparing/reviewing HCP engagement policies and associated trainings. 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 preparation of relevant policies, business rules, and training, as well as contract assistance.
• Advisory Boards: Assisting in the establishment and management of healthcare advisory boards, including review of business needs assessment forms, creation and review of contracts, and review of advisory board presentations.
• Consulting Agreements: Drafting, reviewing, and negotiating HCP agreements, as well as assisting with consideration of business needs assessment forms, processes to allow for documentation of fulfillment, and compliance with federal, state and other obligations related to HCP spend limitations and reporting.
• Compliance Training: Designing, updating and conducting compliance training programs for life sciences companies and healthcare providers. We also facilitate educational initiatives to help companies navigate legal and regulatory requirements.

Patients and Patient Organization Interactions

• Advocacy Plans: Assisting in the development of compliant plans for patient advocacy and patient interactions, identifying risk areas and providing recommendations to help support patients while minimizing risk.
• Outreach Strategies: Guiding organizations on compliant approaches for patient outreach initiatives.

Compliance Assessments, Auditing, and Investigations

• Compliance Programs: Developing comprehensive compliance programs to support successful company activities, including product commercialization. We create detailed strategies encompassing regulatory compliance, risk mitigation, and SOPs to support adherence to legal and regulatory standards at every phase of the commercialization process.
• Compliance/Risk Assessments: Conducting thorough assessments throughout the launch process to review compliance with legal and regulatory requirements and industry guidelines, including pre-launch audits to identify potential compliance gaps, allowing for a proactive approach to prepare for product launch.
• Privacy Compliance: Counseling on privacy considerations throughout the product and services life cycle to help life sciences companies adhere to applicable federal and state privacy requirements, 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.

Research Related Compliance

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

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

• Regulatory Alignment: Counseling on research activities and compliance with evolving regulatory standards.
• Grant Compliance: Advising on compliance requirements for providing research grants.
• Clinical Trial Compliance: Counseling on compliance with regulatory requirements in clinical trials and associated activities.

Commercialization

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