Regulatory Agency Interactions

Pharmacovigilance

Pharmacovigilance (PV) isn’t just a compliance exercise – it’s about demonstrating an ongoing commitment to patient safety. We’ll help you find the optimum approach which combines quality and reliability with efficiency.

Executing the Clinical Program

Taking advanced therapies to market requires that the clinical strategy is expertly crafted to fit the target patient population and indication. We’ll help you execute a clinical program that delivers efficiently and effectively.

Regulatory Agency Interactions

With our deep understanding of how to navigate the regulatory and clinical challenges around advanced therapies, we’ll help you maximize Regulatory Agency interactions, ensuring strong alignment and efficient progress from development to market access.

Accelerated Programs

The regulatory landscape is continuously evolving as the use of new therapies grows and new innovations come to light. Our accelerated programs will help you navigate clinical and regulatory complexity and maximize opportunities in the most efficient way possible.

Quality Management and Compliance

A robust Quality system is not only a regulatory requirement; it also ensures a product’s pharmaceutical quality and patients’ safety. We’ll help you identify gaps in current capability and deliver a fit-for-purpose Quality Management or Pharmaceutical Quality System (QMS/PQS).

Biosimilarity Assessment

The development of biosimilars requires rigorous attention to the manufacturing process due to its impact on the characteristics of the final product: the process occurs in living cells which are inherently variable. We’re highly experienced in this kind of assessment.

Raw Material Assessment

Many biopharmaceuticals, especially cell-based products, use an array of non-standard raw materials in their manufacture. We’ll help you meet your responsibility for assessing and assuring their quality and safety.

Power Of Data Science

Whether your specialism is vaccines/biopharmaceuticals/small molecules/personalized medicines/medical devices, our 40-strong statistical team will help you understand and address the expected statistical deliverables at every stage of development, smoothing regulatory submissions.

Selection of In-Vivo and In-Vitro Models

Once identified, your target compound or therapy will need to be fully validated using in-vitro and in-vivo testing techniques, and our experts will help you determine the most appropriate model.

Safety Assessment

We’ll help you develop a non-clinical safety assessment program that’s scientifically justified and focused and which maximizes the chance of regulatory acceptance – without going further or costing more than is needed.

Cell Line Development and Vector Selection

By helping to hone early decisions around cell line development and vector selection, we’ll ensure you minimize any delays and risks in clinical development and stand up to rigorous due diligence by potential investors.

Characterization

Product specifications are only as good as the analytical methods used to define them. We’re experts in assay development, qualification and validation, and experienced in the demanding potency assays required for complex biopharmaceutical products.

Orphan Designation

Bringing to market novel therapies for rare conditions is something authorities are keen to encourage. Our experts will ensure you identify and take advantage of incentives and fast-track options to bring new drugs to the populations that need them.

Paediatric Strategy

Even if a new drug is not targeted at infants or children, there’s a good chance you will need a paediatric development plan as part of your product strategy. We’ll help you build that into your plans.

Integrated Product Development

Our priority is to help you get the right product into the right markets at the right time, in the right way – by ensuring that decisions now don’t create issues further down the line.

Global Regulatory Strategy

Having a robust global regulatory strategy is essential to any integrated product development effort – ensuring that all official requirements are met and that no major roadblocks will occur at a late stage.

Target Product Profile

All the best plans start with the end in mind. In drug development, that’s the target product profile: so we’ll help you map out who the product is for, and the benefits offered.