Hire us for regulatory results
The aesthetics industry has been pushing the boundary between medicine and cosmetics for several years. Interventions and procedures that contribute to people leading better, more fulfilling lives have reached the point where smart regulatory/quality management is now a necessity. There is no grandfathering of products, and no such category as cosmeceutical. Companies must adequately and carefully manage the regulatory/quality maze for their products, both old and new. If you are in the aesthetics business and are successful at it, you are probably offering for sale medical devices or in some cases biologics and pharmaceuticals.
This new landscape will do one of two things very quickly: become a black hole into which your company will throw millions of dollars to obtain nothing and lose marketshare; or it will become an instrument that will catapult you to greater marketshare with a level of cost competiveness your competition will wish they had.
The regulatory/quality requirements companies now face introduces concepts and heightened burdens the industry has never previously had to negotiate–design control, risk management, pre-clinical testing, clinical testing, post-market clinical follow-up and a host of other requirements for every product it sells, new or old. As you look into your own regulatory needs, you will quickly realize there are more than 20,000 possible processes, procedures, standards, guidance documents, treaties or other requirements on your journey to clearance, however, you may only need a few of them.
How will you make sense of the regulatory maze?
Without sound regulatory skills, policies and procedures, even companies with long and distinguished product lines are at risk for extinction. Every aesthetics company, no matter size or past success, must meet the same set of regulatory requirements.
ABM can bridge the chasm of time, uncertainty and expense and stop them from spiraling out of control. Make us part of your team to cut your time to market and reduce your costs. ABM’s in-house regulatory and quality teams have more than 50 years combined experience with US FDA, Health Canada and EU CE Marking market access. These resources are available now for pre-clinical testing, quality system registration, risk management, HAACP and human clinical trials conducted to GCP and ICH requirements. ABM will integrate regulatory requirements from multiple countries into a single, coordinated effort. Don’t pay for something three times when we can do it once, do it right, do it on time, do it below budget and obtain three market clearances for the investment of one.
Working with ABM represents a superb opportunity. We have the assets you need ready and willing to go. We use them every day to get products into the marketplace with bullet-proof regulatory compliance, with greater speed to market and an investment much less than if you navigated these waters alone. No one can do it like we do.
Avoidance is not a smart alternative. The marketplace is international and FDA, Health Canada and CE Marking are key to your future. ABM is the one team you can count on.
What We Do
- Risk Classification
- Risk Management/Risk Analysis
- Research and Development
- Pre-Clinical Testing
- Organize Third-Party Verification/Validation Testing
- Human Clinical Trials (when necessary)
- Market Clearance Applications
Quality Management System
- Development and Implementation
- Staff Training
- Quality System Registration
- Design Control
Human Clinical Trials
- Protocol Development
- IRB/Regulatory Review and Approval
- Clinical Trial Management
- Clinical Trial Monitoring
- Post-Market Clinical Follow-Up
- Statistical Analysis
- Report Writing
Here’s what you get…
- More Than 20 Years of Experience in the Aesthetics Industry
- More Than 45 Years in Regulatory/Quality Compliance
- Coordinated Regulatory Market Access Submissions
- Reduction of Uncertainty
- Faster Time to Market
- Cost Savings