Pipeline Review & Optimization – Skilled evaluation and prioritization to effectively manage regulatory risk

Clinical Programs – Specialized guidance and strategic design of nonclinical, pre-clinical, and clinical programs

CMC Strategy – Risk-based design and effective implementation of phase-appropriate CMC solutions

Pathway Decisions & Eligibility – Expert support on product classifications, special designations, and expedited program pathways

Regulatory Meetings & Communications – Actionable strategies and insight for milestone meetings and regulatory communications

Regulatory Policy Guidance – Customized solutions to understand, implement, and comply with regulatory policies and programs

Marketing, Promotion & Labeling – Strategic direction on labeling requirements, promotional materials, and marketing programs

Lifecycle support – Valuable expertise throughout the product lifecycle, including post-approval requirements and commitments

Global Support – Trusted guidance when navigating and complying with global pharmacovigilance regulations

Adverse Event Reporting – Systematic identification, objective analysis, and strategic guidance responding to unintended occurrences

Regulatory Reporting – Technical skill and institutional knowledge of complex regulatory reporting obligations

Signal Detection – Expert development and implementation of detection processes, including reporting and risk communication

Risk Assessment & Management – Proactive identification, assessment and planning to manage potential risk and ensure regulatory compliance

Post-Marketing Surveillance – Established network experts to support commercial product safety systems and reporting functions

Risk Communication – Strategic development of communications plans to address emerging safety concerns and instill confidence in the market

Clinical Trials Safety Oversight – On-demand resources to support safety monitoring before and after regulatory approval

Quality Systems – Objective evaluation and expert direction on quality system design, optimization & implementation

Inspectional Readiness – Customized strategies to prepare for inspections and align with regulatory expectations

Compliance & Enforcement Actions – Proven expertise when responding to regulatory compliance and enforcement actions

Regulatory Meetings & Communications – Valuable guidance on regulatory communications, meetings, and correspondence

Good clinical practices – Risk-based methodology applied to the design and improvement of clinical quality systems

Laboratory Controls & Data Integrity Systems – Tailored solutions to ensure data integrity and manufacturing excellence

Supply Chain Optimization – Skilled support to evaluate and strengthen supply chain management practices

Consultation, Training and Regulatory guidance – Strategic insight and actionable strategies spanning the product lifecycle

Compliance Assessments – Strategic and technical evaluations to identify areas of non-compliance & mitigate other potential risks

Rapid Response – Immediate deployment of compliance experts to provide valuable on-site support when time is of the essence

Customized Solutions– Actionable remediation plans to correct known problems, prevent future occurrences, and meet regulatory expectations

Corrective Action Plans – Design and enable action plans that are both effective and sustainable for your business

Comprehensive Communications – Valuable direction when interacting with and effectively responding to regulatory communications

Implementation Expertise – Tailored support to implement both acute and systemic improvements across facilities and product lines

On-Demand & On-Site – Skilled resources ready to support implementation plans, sustain compliance, and respond to evolving demands

Third-Party Reporting – Trusted third-party reporting of progress against improvement commitments

Maintenance & Monitoring – Uphold the integrity of implemented practices with ongoing monitoring and maintenance programs

In-person, virtual & on-demand training for teams, private groups, and individuals

Regulatory policies & procedures – Expert instruction on all aspects of regulatory programs across the product lifecycle

Quality Systems – Foundational and in-depth learning programs on quality management systems across the regulatory landscape

Inspectional readiness – Specialized programs to ensure readiness prior to regulatory inspections

Customized training programs – Flexible options to develop training programs on a variety of regulatory subjects