Raising the bar to help you achieve regulatory compliance
Complya Consulting Group provides Quality Assurance (QA) and Regulatory Affairs (RA) consulting services for virtual, operating, and contract manufacturing companies in the biotechnology, pharmaceutical and medical device sectors. With nearly 50 consultants actively working today, Complya services clients in North America, Europe and Asia with auditing and longer-term, ongoing needs.
At Complya, we understand that Quality Assurance and Regulatory Affairs are critical operations within your business infrastructure that must be handled by people with the skills and experience to ensure compliance, integrate with your other departments, and deliver results. This is our specialty.
Complya works across 5 Pillars to provide all the elements our clients need to get the job done efficiently and effectively.
We get the job done We are action-oriented. Your time is valuable, so we roll up our sleeves and focus on delivering compliant, sustainable results.
An extension of your team Our consultants will take ownership of the work, fit right in, fill the gaps and work collaboratively with you. We do not take an “us versus them” approach. We can run your meetings, manage your vendors, investigate your deviations or prepare your filings.
The right fit After managing hundreds of projects, we refined our 5-step PEARL Matching Process to ensure that you get the right expertise level, personality and cost for the maximum value on each project.
A deeper bench Our consultants are never working alone on an island because we provide them with access to Complya’s library of resources and templates along with our internal support staff. With our wide range of talented, experienced consultants, you are never left hanging if a project needs more help, an additional set of skills, or a complex question answered.
Validated decision-making We make decisions and recommendations based upon logic, precedent and a thorough knowledge of the regulatory process. This ensures that your results are clear and defensible long after we have gone.