Signed in as:

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 speciality (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.

Our Regulatory Expertise: