Product Development
Development
PRODUCT DEVELOPMENT
Strategic pipeline orchestration from candidate selection to market authorisation.
Accelerating approval and launch readiness through synchronised clinical, non-clinical, and CMC development strategies.
The pre-approval phase is where the foundation of a product’s entire lifecycle is built.
Decisions made early—on development strategy, regulatory pathway, Chemistry, Manufacturing, and Controls (CMC) approach, non-clinical programme design, and supply chain—shape everything that follows. They dictate your clinical timelines, overall development costs, health authority approval probability, and long-term commercial market viability.
Moving an asset from discovery to authorization requires a masterful combination of scientific rigor and cross-functional execution to avoid costly development delays.
Our Expertise
PLG brings together senior experts across regulatory affairs, clinical development, non-clinical sciences, CMC, and quality to support life sciences companies at every stage of development — from early candidate selection through to submission readiness and first approval.
Our integrated approach means your scientific, regulatory, and operational strategies are designed to work together, not in silos.
By coordinating these complex milestones under a single framework, we help you shorten time to approval and move forward with the absolute confidence that your non-clinical safety, clinical strategies, CMC development, and supply chain are compliant and aligned end-to-end.
Overcoming systemic silos in early-stage asset development.
The primary point of friction for modern biopharma and device innovators is the disjointed nature of early-stage asset management. When non-clinical toxicology teams, clinical operations groups, and CMC engineers operate independently, critical data gaps inevitably emerge.
A lack of alignment between your early safety data and your downstream clinical design can result in severe health authority hold orders, unexpected validation failures, or protracted review timelines that drain venture capital or corporate resources.
PLG eliminates this operational exposure by serving as your unified development engine.
Whether you are advancing a novel biopharmaceutical, a complex medical device, or an innovative consumer health product, we provide the technical expertise, global regulatory intelligence, and strategic oversight required to bridge the gap between discovery and commercialisation.
We replace fragmented, reactive planning with a proactive development roadmap that synchronises data generation with health authority expectations, helping you move faster — and with greater confidence — towards the market approval that matters.
Product Development
related services
Our core development framework unifies seven essential service disciplines to deliver complete lifecycle alignment across global jurisdictions.
Defining the optimal regulatory, development, and approval pathway from early asset planning through to final submission readiness across international markets.
Designing and overseeing the specialised pharmacology, toxicology, and safety studies required to safely bridge discovery to first-in-human trials and secure long-term regulatory success.
Providing data-driven clinical strategies and deep operational expertise to support clinical evaluation programs, trial operations, and robust evidence generation.
Delivering end-to-end clinical trial expertise in Italy and Spain, from first-in-human studies to post-approval phases, fully integrated with your broader regulatory and market access strategy.
Supporting both pre-clinical and clinical development all the way through to final dossier submission with expert-based quantitative insights and modelling.
Advancing products smoothly through technical development, pharmaceutical manufacturing readiness, scaling validations, and absolute regulatory alignment.
Establishing compliant, right-sized quality systems and compliance frameworks tailored to support health authority inspection readiness and ensure total operational reliability.
Product Development
Susan Maue
BU Managing Director
"The most expensive development problems are the ones built in early and discovered late.
A non-clinical package that doesn't anticipate the clinical plan, or a CMC strategy that can't scale, will surface eventually, usually at the worst possible moment.
That's why we run development as one strategy, not a relay between functions.
Our job is to make sure every early decision still holds when the dossier reaches the regulator."