Realize the full potential of business value while mitigating the business risks with risk compliance and governance consulting from Pilothouse Advisors. Our expert risk compliance and governance business consultants help our clients implement policies and controls that are based in industry best practices and ensure that our clients meet business and regulatory requirements.
Our risk compliance and governance consulting helps our clients identify, understand and manage risk management systems within existing and startup businesses, providing an overall assessment of business risks and opportunities with the desire to provide continuous growth. At Pilothouse Advisors, we investigate our clients’ current risk management systems, as well as compliance standards, and provide detailed reports that assist the business to continue operating within relevant legislation and regulations.
Professional Business Consultants with Proven Risk Compliance & Governance Experience
At Pilothouse Advisors, our risk compliance and governance clients find improved risk management, control and governance process through our in-depth evaluation and reporting protocol. Our expert consultants interprets business regulations and corporate governance standards, ensuring that our clients are operating their businesses within the proper standards and legislation. Our advisors offer risk assessments in various industries, including:
- HIPAA security provision reviews
- SOX 404 financial
- IT controls design & testing assessments
Our team will conduct independent object compliance and consulting internal audit engagements, helping our clients to identify procedure recommendations for process improvements that support corporate objectives. Our internal audit capabilities include internal audits, testing of internal controls and control framework reviews (e.g., COSO 2013).
Additionally, we provide Services Organization Control (SOC) Reporting, and aid in defining the type of SOC report that is most beneficial to your clients. Our industry expertise works with our clients to perform the related examination procedures and protocols, including readiness assessments and SOC 1, SOC 2 and SOC 3 attestation reports.
- Manage a team of professional regulatory affairs experts responsible for lifecycle management of licensed biological products
- Supervise and coach team members in fulfillment of their functions
- Promote functional excellence in the Lifecycle Management Biological team with the goal to foster innovation as well as optimize time to market and reduce project and portfolio risks
- Manage in conjunction with other functions and in alignment with overall company strategies
- Set working priorities within a team and communicate with them routinely
- Manage official contacts with the US authorities for licensed biological products
- Maintain open dialogue with USDA contacts and work with a center for veterinary biologics to implement priorities as agreed and in alignment with company objectives
- Provide representation and point of contact, as assigned, for local, state and federal regulatory inspections
- Supervise, develop and implement regulatory strategies necessary
- Optimize position of company products in the market by regulatory means
- Implement manufacturing strategies
- Maintain products throughout the lifecycle in line with agreed priorities, including routine regulatory activities and take into account the possible future evolution of the regulatory environment
- Lead communications and serve as a principle point of contact with Business Operations, Industrial Operations and other departments as regulatory strategies are developed and implemented in order to achieve business and manufacturing strategies, while accounting for regulatory threats, opportunities, constraints and future changes
- Ensure regulatory compliance of licensed company biological products throughout their lifecycle
- Ensure proper regulatory management of changes, deviations, exemptions, notifications, etc. in close collaboration with Industrial Operations, Quality Assurance, R&D, Pharmacovigilance, Business Operations and others
- Prepare core regulatory documents for product renewals, variations, country extensions, etc., as assigned
- Ensure regulatory compliance of labels by establishing and maintaining the regulatory files for labels
- Prepare labels and submissions based on applicable regulations in cooperation with Business Operations, Supply and others as appropriate
- Manage regulatory submissions and all necessary follow up
- Provide or supervise regulatory expertise and advice, as appropriate, to other functions or interdisciplinary Project teams (in-line product management, launch teams, etc.)
- Review draft regulatory texts, appropriately comment and propose amendments to draft requirements in alignment with company needs
- Maintain tools (records, schedules, reports, database, etc.) for timely management of regulatory activities