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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.

Services

Product Development
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Our core development framework unifies seven essential service disciplines to deliver complete lifecycle alignment across global jurisdictions.

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Regulatory & Development strategy

Defining the optimal regulatory, development, and approval pathway from early asset planning through to final submission readiness across international markets.

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Non-Clinical Development

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.

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Clinical Development & Operations

Providing data-driven clinical strategies and deep operational expertise to support clinical evaluation programs, trial operations, and robust evidence generation.

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Clinical Research Organization (CRO) – Italy and Spain

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.

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Pharmacometrics & Clinical Pharmacology

Supporting both pre-clinical and clinical development all the way through to final dossier submission with expert-based quantitative insights and modelling.

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CMC Development & Supply Chain

Advancing products smoothly through technical development, pharmaceutical manufacturing readiness, scaling validations, and absolute regulatory alignment.

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Quality & Compliance

Establishing compliant, right-sized quality systems and compliance frameworks tailored to support health authority inspection readiness and ensure total operational reliability.

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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."

 

Frequently asked questions

It covers the full pre-approval journey, from candidate selection to first marketing authorisation. PLG brings together seven disciplines: Regulatory & Development Strategy, Non-Clinical Development, Clinical Development & Operations, a CRO in Italy and Spain, Pharmacometrics & Clinical Pharmacology, CMC Development & Supply Chain and Quality & Compliance. They can be engaged individually or as one coordinated programme.
Because gaps between them are the most common cause of late, costly delays. A toxicology package that does not anticipate the clinical plan, or a CMC process that cannot scale, can lead to clinical holds, validation failures or long review cycles. PLG runs development as one strategy, so early decisions still hold when the dossier reaches the regulator.
Ideally at candidate selection or before the first regulatory interaction. Early choices on regulatory pathway, non-clinical design and CMC approach shape timelines, costs and approval probability. PLG also joins programmes already under way, for example to prepare an IND or CTA, recover from an agency question, or get a dossier submission-ready.
PLG prepares development strategies and submissions for the EMA, the FDA and national authorities worldwide. With ~1,750 experts, 50+ offices and coverage of 150+ countries, the team combines global regulatory intelligence with local knowledge of each agency's expectations, including scientific advice meetings and accelerated pathways.
Yes. PLG offers clinical strategy, trial design and operational oversight, and acts as a full-service CRO in Italy and Spain, from first-in-human studies to post-approval phases. Elsewhere, PLG provides CRO selection and governance, so that the evidence generated is robust, submission-ready and aligned with payer expectations.
Pharmacometrics uses quantitative models, such as population PK and PK/PD modelling, to predict how a drug behaves in patients. It supports dose selection, trial design and regulatory justification from pre-clinical stages through to dossier submission, reducing uncertainty and the number of studies needed. PLG's Pharmacometrics & Clinical Pharmacology team provides this expertise.
No. The same integrated approach supports novel biopharmaceuticals, complex medical devices and innovative consumer health products. The regulatory frameworks differ, but the principle is the same: align data generation with health authority expectations from the start, to move faster and with more confidence towards approval.