How We Help
Our consultants are highly specialized within three areas of focus. Within those areas, we can help with day-to-day sustaining work, regulatory submissions/filings, remediation activities, audits, research & development, capital expansion projects and other pre/post market activities.
Our Core Service Offerings
Interim Consulting Solutions
Our consultants offer various levels of expertise and experience. Whether it is a one-off for an audit, a large remediation project, or sustaining work, Ardence Consultants hit the ground running to ensure our clients’ productivity and operations continue to run smoothly.
Project Team Deployment
Many clients prefer to bring on a project team within a specific specialized function. We can customize and scale all our project teams to meet each client’s specific requirements and timelines.
Functional Service Provision
An FSP allows flexibility for an organization to get back to the basics of running their business. This is like our project team offering, but on a larger scale and across multiple functional areas. Our FSP offering could include remediation projects, monitoring projects, and integration projects across Quality, Regulatory, and Clinical Operations. This provides our client a cohesiveness within their own systems, as well as an efficient use of time to get projects completed quickly/effectively, allow flexibility of workforce, and create cost efficiencies.
Our Functional Capabilities
Engineering & Operations
Common areas of focus include but are not limited to: Mechanical, R&D, Design Quality, Manufacturing, Process, Systems, Software Development, Software Test, Electrical, Validation, Project & Program Management, and Supply Chain.
Quality & Regulatory Compliance
Quality and Regulatory Compliance offerings including but are not limited to the following: Quality Assurance, Quality Systems, Regulatory Submissions (domestic and international), Regulatory CMC, Regulatory Operations, Quality Operations, Technical Writing, Project Management, Program Management, Product Launch, Post-Market Regulatory Advertising/Marketing, etc.
Clinical & Medical
Clinical and Medical include but are not limited to: Clinical Research, Clinical Operations, Drug Development, Preclinical Activities, Biometrics, Medical Writing, Medical Science Liaison, Clinical Trial Management, Clinical Program Management, Drug Safety, Clinical Pharmacology, HEOR, etc.