Regulatory Assistance

Regulatory Consulting

We have expertise in compliance, equipment validation and maintenance, cleanroom design and validation, Quality Systems – SOPs and Training, and more. We can help you establish your own regulatory path – contact us to discuss your compliance needs.

FDA Filings

We’ve been down the FDA road several times and can leverage our experience to help you in your own pharmaceutical journey. Your filings can be easier with our help – we have experience in several areas and can accelerate your timeline.

Facilities Design

GMP facilities and cleanroom manufacturing are a specialty (and passion) of ours. Puzzled by the intricate workings of these elements? We can assist in the planning, design, execution, training – even with understanding industry pricing for equipment and labor. Just let us know.

How & Why We can Help You

Our on-site staff has over a century of familiarity with regulatory aspects of the pharmaceutical industry combined – we can bring this benefit to you, to help with your needs and speed your timelines. We’d be glad to share more information about the specifics of our staff competencies and how we can help you.

Chat with the experts.

We’d love to understand your needs and help your patients.