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Regulatory Assistance

Regulatory Consulting

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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

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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

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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: