Our team provides high-quality compliance, regulatory, and validation services to the biotechnology and pharmaceutical community. Our mission is to deliver extraordinary service offerings precisely aligned with our client's requirements. With a thorough understanding of biotech and pharmaceutical operations, and the regulatory challenges facing these industries, we have the experience, the skills, and the talent to provide efficient and cost-effective solutions. We strive to develop long-term relationships in the biopharma community.
Whether you’re a start-up that requires high-level consulting about compliance, regulatory, or validation strategies or an established organization with targeted requirements for a specific project, you have a vision for achieving your organization’s milestones.
We learn about your business, project, and methodologies, then provide you support with our technical skills, professional demeanor, and attention to detail. Our talented personnel are committed to understanding your needs and delivering practical validation, regulatory, and compliance outcomes.
Full compliance with regulatory requirements is the cornerstone of successful product development. From FAT support to high-level validation approaches to detailed on-site services, our professionals can help with the validation of:
Successful compliance requires knowledge of the current regulatory environment and effective quality/risk management. We can help with:
An effective validation master plan ensures aligned expectations, informed commitments, and improved budgeting, scheduling and project management. Our experts can help develop a plan to:
Credible audits are essential for demonstrating and maintaining compliance. Our professionals can help with:
Our experienced regulatory consultants can assist with early stage strategy discussions through IND submissions, for US, EU and Rest of World, including:
We can help develop and promote employee behavior that aligns regulatory requirements with business goals, including: