CONTACT

VOLKANO LABS INNOVATION

We’re Changing the Way the World
Looks at Quality and
Manufacturing.

In a complex world of regulations and quality assurance, Volkano Labs is a premier FDA quality consulting group. With decades of experience solving complex quality and manufacturing issues. Our professionals have unmatched experience in multiple industries including Cosmetics, Personal Care, Oral Care, OTC, Dietary Supplements. 

QUALITY

ASSURANCE

INNOVATION

Quality Assurance and Manufacturing Consultants Servicing Cosmetics, Personal Care, Oral Care, OTC and Dietary Supplements.

QUALITY

MANUFACTURING

PERSONAL

QUALITY

ASSURANCE

INNOVATION

FDA QUALITY CONSULTING

Our FDA Quality Assurance Consulting Services ensure your organization meets and achieves the highest regulatory standards. We provide comprehensive guidance, audits, and compliance strategies to streamline your FDA concerns and gaps. Our expert team offers tailored solutions, reducing risks, and ensuring  your  organization  operates with confidence. The FDA journey doesn't have to be difficult.

QUALITY MANAGEMENT SYSTEM DESIGN

Quality Management Systems (QMS) are paramount in today's business landscape. They serve as the foundation for consistent product and service excellence. By establishing clear processes, documentation, and standards, QMS ensures that organizations meet customer expectations, comply with regulations, and drive continual improvement. Effective QMS not only enhances product quality but also builds trust with customers, partners, and stakeholders, fostering long-term success and competitiveness in the market.

QUALITY

ASSURANCE

INNOVATION

DESIGN

FORMULATIONS

MANUFACTURING

MANUFACTURING/ FORMULATIONS
ADVISING & DESIGN

Our expert team comes with decades of experience working with some of the largest brands designing facility layouts and installing complete manufacturing systems, and production line equipment. If you have complex formulation issues, we have solutions. We can design and develop any part of the process, including the backend Quality Management System (QMS) component for your manufacturing organization.

R&D LABORATORY SETUP & SUPPORT

With a steadfast commitment to innovation & excellence, our team pioneers solutions that meet and exceed your expectations. Fueled by expertise and creativity, we navigate complexities with cosmetic R&D lab setup. Our collaborative approach cultivates synergy, propelling us to exceed expectations and drive sustained growth in an ever-evolving competitive landscape. Our team can create your new lab or redesign your current one

PIONEERS

EXCELLENCE

INNOVATION

We offer many other innovative solutions to your organizations needs.
 Professional Services:

MANAGEMENT

DEPLOYMENT

DEVELOPMENT

INNOVATION

QMS DEVELOPMENT & IMPLEMENTATION

Quality Management Systems are critical to get right. Our QMS Development team will audit for 4 days conducting gap analysis, work plan development, and post-implementation to ensure successful deployment of the system.

TRUST

IN-DEPTH FACILITY & 
SUPPLIER AUDITS

Auditing suppliers is often overlooked but can have dire consequences when neglected. We can manage and set up the entire process complete with supplier ranking tools as well as ongoing monitoring of your supplier.

DILIGENCE

QMS GAP ANALYSIS &
AUDITS

Our team utilizes proprietary site performance benchmarks that are carefully analyzed and reported on. We can audit against many different regulatory schemes like FDA/CFR, ISO, GFSI, or hybrid schemes.

DILIGENCE

MERGERS & ACQUISITION
ADVISORY SERVICES

Our expert team will perform a brand compliance assessment as well as on-site quality audit. We provide a detailed risk report as well as  recommendations for improvements. We offer fractional support if needed.

MANAGEMENT

DEPLOYMENT

DEVELOPMENT

“Be a yardstick of quality. Some people aren’t used to an environment where excellence is expected.”

STEVE JOBS