North America
With the acquisition of DSI in 2021 and Halloran Consulting Group in 2024, ProductLife Group significantly expanded its North American presence, strengthening the North American capabilities for supporting the development, approval, and lifecycle success of innovative therapies, medical devices, and combination products. As established leaders in regulatory affairs, quality and compliance, CMC development, organizational excellence, clinical development and operations, and pharmacometrics and model-informed drug development (MIDD), DSI and Halloran together position PLG as a premier global partner for pharma, biotech, and medtech companies. By uniting the deep expertise of both organizations, PLG North America now delivers an integrated suite of consulting and operational solutions for pharmaceutical, biotech—including human and animal health—and medtech companies navigating FDA and Health Canada pathways, while also connecting clients to PLG’s broader global capabilities for expansion into Europe, Asia, and other key markets.
PLG North America
PLG North America supports domestic and international pharma, biotech, and medtech sponsors as an integrated partner across regulatory affairs, quality and compliance, CMC development, organizational excellence, clinical development and operations, and pharmacometrics and model-informed drug development (MIDD). We provide the expertise needed to prepare for, navigate, and sustain success through FDA and Health Canada submissions, approvals, and post-approval requirements. For clients based in North America, we combine local execution with PLG’s global platform to support expansion into Europe, Asia, and other key regions. For clients outside North America, we help secure access to the US and Canada through regulatory strategy, submission support, and US Agent services.
Halloran
Halloran is a life science consulting firm that partners with pharmaceutical, biotech, and medtech companies to develop strategies and solutions that accelerate the delivery of lifesaving scientific and medical innovations. Through its consulting services, Halloran helps sponsors navigate complex development challenges and bring transformative therapies to patients in North America and globally.
DSI - DS Inpharmatics
DSI provides senior CMC, Quality Assurance, and Regulatory Affairs consultants who drive programs forward with practical, hands‑on leadership. Its strength in CMC development, quality, and regulatory execution helps clients reduce technical risk, strengthen manufacturing readiness, and keep programs aligned with regulatory expectations. Alongside its human-health expertise, DSI also supports animal-health developers with regulatory and CMC guidance for USDA and FDA-CVM pathways. Whether working directly with clients or coordinating through CDMOs, DSI is known for solving development challenges and implementing practical, real-world solutions
PLG North America
PLG North America (PLG NA) is the North American affiliate of Product Life Group (PLG) LLC— a global life sciences partner delivering specialized consulting, operational, and technical expertise to pharma, biotech, and medtech organizations. While PLG has supported U.S. clients for many years from its European base, the acquisitions of DSI and Halloran Consulting Group marked a strategic shift: establishing PLG North America as our dedicated U.S. presence and strengthening our ability to support clients across regulatory affairs, quality and compliance, CMC development, organizational excellence, and clinical development and operations
With the integration of DSI, PLG NA also brings long‑standing, specialized expertise in animal health, supporting veterinary pharmaceutical and biologics companies with regulatory strategy, dossier preparation, and lifecycle management. DSI’s deep understanding of USDA and FDA‑CVM pathways strengthens our ability to guide clients developing products for both companion animals and livestock, expanding PLG NA’s reach across the full spectrum of human and animal health innovation.
Our mission is to help North America-based and international life sciences companies move programs forward with confidence—combining strategic expertise and executional support to advance products through FDA and Health Canada pathways. As part of global PLG, we also help North America clients expand into key markets worldwide, while supporting companies outside North America in gaining access to the U.S. and Canada.
Scalable Expertise Across Regulatory, Clinical, Quality & Program Leadership
PLG North America provides specialized expertise in regulatory affairs, clinical development and operations, quality & compliance, and program leadership to help clients move 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 partnering closely with your internal stakeholders. Whether you are 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
PLG North America helps clients do more than secure regulatory approval in North America—we help them build the regulatory, quality, clinical, quantitative development, and operational foundation needed for successful market entry, sustainable growth, and long-term product success. Our North America team supports pharma, biotech, and medtech companies with FDA and Health Canada strategy and execution, including support in pharmacometrics and model-informed drug development (MIDD) to strengthen dose selection, optimize trial design, reduce development risk, and support regulatory decision-making. At the same time, PLG’s global platform helps North America-based clients expand into Europe, Asia, and other international markets. We also support companies outside North America with the regulatory strategy, submission support, and US Agent services needed to gain access to the US and Canada.
Digital & Data Innovation
Our Digital Innovation (DI) team complements this expertise with end-to-end digital solutions that streamline development, strengthen regulatory readiness, and improve performance across the product lifecycle. From data and analytics to digital trial enablement, platform development, and automation, DI helps create a more connected, efficient, and scalable operating environment for life sciences organizations.
Projects
350+
Projects Per Year
Our Service Capabilities
Regulatory & Development Strategy
· Regulatory pathway design, submission planning, and multi-regional strategy.
· Health authority meeting preparation and support, including pre-submission and scientific advice interactions.
· Global regulatory intelligence, dossier strategy, and approval planning across key markets.
Non-clinical and Clinical Development & Operations
· Non-clinical and clinical development strategy from early development through later-stage programs.
· Clinical study execution, operational support, and trial management.
· Medical writing and evidence package development, including study reports and integrated summaries.
CMC Development & Supply Chain
· CMC roadmaps, technical writing, and submission-ready documentation.
· Pharmaceutical development, manufacturing readiness, and analytical / 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 / 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/advocacy support to strengthen market access planning.
Regulatory Operations, Pharmacovigilance & Medical Information
· eCTD publishing, submission operations, RIMS, and regulatory documentation 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