North America
PLG North America: Your global partner for life sciences-delivering local expertise with worldwide reach.
PLG North America (PLG NA) – is the North American affiliate of ProductLife Group (PLG) a global life sciences partner delivering specialized consulting, operational, and technical expertise to pharmaceutical, biotech, and medtech organizations.
For many years, PLG supported U.S. clients from its European base. The acquisitions of DSI (2021) and Halloran Consulting Group (2024) marked a strategic shift – establishing a strong local presence and significantly enhancing our ability to serve clients across North America while also giving our clients access to a global network of development services.
Today, PLG NA provides global capabilities in integrated product development from concept through approval and commercialization across all major functions. Our capabilities includes regulatory, nonclinical, CMC, clinical, and quality and compliance. Our expertise includes but is not limited to regulatory strategy agency meetings and submissions, quality and compliance, CMC development, organizational excellence, clinical development and operations, and pharmacometrics, including model-informed drug development (MIDD).
This expertise is further strengthened by our Digital Innovation capabilities enable clients to leverage data, analytics, digital trial solutions, platform development, and automation to create more connected, efficient, and scalable operating environments. Delivered through a global team with resources in both Europe and North America, our advanced human and artificial intelligence capabilities allow us to support U.S. clients with flexible, cross-regional integrated product development solutions.
We combine local execution with global reach – making us the partner of choice for companies both within and outside the United States. For North America-based clients, we enable efficient expansion into Europe, Asia, and other key markets. For companies outside North America, we provide regulatory, clinical, quality, and CMC expertise as well as submission support, and U.S. Agent representation to facilitate entry into the U.S. and Canadian markets.
With the integration of DSI, PLG NA also brings deep, specialized expertise in animal health. We support veterinary pharmaceutical and biologics companies with regulatory strategy, dossier preparation, and lifecycle management. Our strong understanding of USDA and FDA-CVM pathways enables us to guide development across both companion animal and livestock products – expanding our reach across the full spectrum of human and animal health innovation.
Our mission is to partner with life sciences innovators at every stage of development – combining strategic expertise with hands-on execution to move programs forward with confidence. We bring together deep human expertise and intelligent ways of working to help clients achieve the right outcomes with speed, quality, and accountability.
Halloran
Halloran Consulting Group is a life science consulting firm that accelerates the delivery of life-changing medical innovations through integrated product development solutions. They partner with pharmaceutical, biotech, and medtech companies to develop strategies and solutions that overcome complex development challenges and bring transformative therapies to patients faster in North America and beyond.
DSI
DSI provides senior-level CMC, Quality Assurance, and Regulatory Affairs consultants who drive development programs forward with practical, hands‑on leadership. DSI’s strengths in CMC development, quality, and regulatory execution help clients reduce technical risk, enhance manufacturing readiness, and stay aligned with regulatory expectations. In addition to human health projects, DSI also supports animal health developers with regulatory and CMC guidance for USDA and FDA-CVM pathways. Whether working directly with clients or coordinating with sponsors or CDMOs, DSI is known for solving tough development challenges and implementing real-world solutions
Scalable Expertise Across Regulatory, Clinical, Quality & Program Leadership
PLG North America provides specialized expertise in regulatory affairs, clinical development & operations, quality & compliance, and program leadership to propel your critical programs forward with confidence. We deliver high‑impact project support at the moments that matter most-whether you need strategic guidance, executional expertise, or added leadership capacity to meet a key milestone.
Our teams integrate quickly into your environment, working remotely or on-site and collaborating closely with your internal stakeholders. Whether you are beginning your development journey, preparing for a submission, managing increased engagement with health authorities, navigating a complex development challenge, or responding to shifting resource needs, PLG North America brings the technical depth, executional discipline, and scalable support needed to keep your programs advancing.
What We Deliver Beyond Approval
We do more than just secure regulatory approval – PLG North America helps build the regulatory, quality, clinical, quantitative development, and operational foundation for successful market entry, sustainable growth, and long-term product success. Our team supports companies with FDA and Health Canada strategy and execution, including advanced pharmacometrics and model-informed drug development (MIDD) to strengthen dose selection, optimize trial design, reduce development risk, and support regulatory decision-making. Meanwhile, PLG’s global network enables North America-based clients to expand into Europe, Asia, and beyond. We also help international companies enter the U.S. and Canada through regulatory strategy, submission support, and US Agent representation.
Digital & Data Innovation
Our Digital Innovation (DI) team provides end-to-end digital solutions that streamline development, strengthen regulatory readiness, and improve performance across the product lifecycle. From data and analytics and digital trial enablement to platform development and process automation, DI helps create a more connected, efficient, and scalable operating environment for life sciences organizations.
Our Service Capabilities
Regulatory & Development Strategy
- Integrated product development solutions ensuring efficient and time- saving strategies and execution
- Gap analyses and regulatory readiness assessments
- Integrated cross-functional development roadmaps including regulatory pathway, clinical development programs, CMC strategies and quality planning
- End-to-end support for health authority interactions across the development lifecycle, including all types of Agency meetings, submissions, and special designations
- Global regulatory intelligence, dossier strategy, approval planning across key markets and lifecycle maintenance activities.
Non-clinical and Clinical Development & Operations
- Non-clinical and clinical development strategy from early development through late-stage programs, including study design and protocol authoring.
- Clinical study execution, operational support, and trial management.
- Medical writing and evidence package development, including all types of regulatory and clinical documents, study reports, and integrated summaries.
CMC Development & Supply Chain
- CMC roadmaps, technical writing, and submission-ready documentation.
- Pharmaceutical development, manufacturing readiness, and analytical and formulation support.
- CDMO coordination, tech transfer, and supply chain planning to support development through launch.
Quality & Compliance
- GxP audits, inspection readiness, and quality strategy support.
- Quality assurance leadership, QMS support, and SOP and CAPA development.
- Compliance remediation, supplier qualification, and digital quality system support.
Pharmacometrics & Clinical Pharmacology
- Model-informed drug development and regulatory-grade quantitative strategy.
- First-in-human dose justification, exposure-response modeling, and clinical trial simulation.
- Submission-ready analyses integrated with clinical, regulatory, and CMC programs.
Market Access & Commercial Readiness
- Early-stage market access strategy to support approval, launch planning, and long-term commercial success.
- Market access and pricing strategy, including support for entry into North America and other key global markets.
- HTA, pricing & reimbursement, and health economics/modeling support.
- Value evidence, medical strategy, and policy and advocacy support to strengthen market access planning
Regulatory Operations, Pharmacovigilance & Medical Information
- eCTD publishing, submission operations, RIMS, regulatory documentation management and lifecycle management.
- Pharmacovigilance system support, including PSMF, SDEA, audit/inspection support, and QPPV or local safety services.
- End-to-end case management across clinical and post-marketing activities, including ICSR processing, safety database support, and regulatory reporting.
- Medical information and literature monitoring, including inquiry handling, literature research, and local/global literature surveillance.
- Pharmacovigilance medical writing, including PSUR / PBRER, PADER, and DSUR support.
Our Team
ProductLife Group North America Office
245 Main St., Cambridge, MA, 02142 USA