pharmacovigilance.
Clinical Research
Research processes that are absent, unfocused, or cumbersome can overcomplicate a research study or, worse, set a stage for noncompliance. We help evaluate your department’s weaknesses and address your needs, assisting with conducting well-controlled, compliant clinical research trials. Our consultants can help you earn approval from the FDA or international regulators. We achieve this by guiding teams through the entire clinical trial lifecycle. We also offer assistance with particular elements of the process, providing consulting, independent monitoring, auditing, data management, strategic services, and more.
Clinical Development
Our consultants help accelerate clinical development with a comprehensible strategy, operating model design, and process optimization – all with efficient governance. Our expertise across consulting, strategy, technology, and operations assists our clients as they work to streamline their clinical development programs. We identify and support label claims and strategies for efficient product application, regulatory strategy planning and offer assistance with CTAs, INDs, NDAs, and MAAs; pharmaceutical and biopharmaceuticals GMP and GLP compliance, compliance strategies, and due diligence assessment.
Strategic Development
Our strategic advice is based on therapeutic class individuality, specific aspects of the asset (formulation, route of administration), concerned FDA expectations, target population, and disease indication. We help our clients meet the challenge of developing new products against a landscape of complex regulation, thinning opportunities, and changing physician, payer and patient expectations. We help you de-risk regulatory interactions – submissions and responses – and provide ongoing, hands-on regulatory support in interactions with the FDA, EMA, MHRA, Health Canada, TGA, ANVISA, other national regulators.
