We help you ensure stage-appropriate compliance systems so your program stays aligned with “Quality by Design” principals and ahead of the curve – without wasting resources, capital, or generating excessive bureaucracy.

QMS Design:
We help you develop a Quality Management System (QMS) that meets the unique needs of your program and stage of development.

QMS Gap Assessment:
We analyze your existing QMS, identify any gaps, and provide stage appropriate and resource efficient solutions to address those gaps.

Document authoring, review and revision:
We write your SOPs, policies, and other controlled documents, or provide expert review and revision of existing documents.

Supplier Oversight:
We perform risk assessments and/or audits of critical raw material suppliers, contract manufacturers and analytical service providers to ensure their quality standards are aligned with your needs.

Audits: both in-person and virtual options:
Historically, audits are done on-site and in person. However, due to our clients’ needs during the CoVID-19 global pandemic, we’ve built a new offering: the Virtual Remote Audit. Take a look at this flyer for more information and put in a request for a consultation if this might be a fit for you as you work to move your program forward in these unusual times.

Quality Systems

Quality By Design

We help you ensure stage-appropriate compliance systems so your program stays aligned with “Quality by Design” principals and ahead of the curve – without wasting resources, capital, or generating excessive bureaucracy.

QMS Design:
We help you develop a Quality Management System (QMS) that meets the unique needs of your program and stage of development.

Supplier Oversight:
We perform risk assessments and/or audits of critical raw material suppliers, contract manufacturers and analytical service providers to ensure their quality standards are aligned with your needs.

QMS Gap Assessment:
We analyze your existing QMS, identify any gaps, and provide stage appropriate and resource efficient solutions to address those gaps.

We use cookies to help give you the best experience on our website. By continuing you agree to our use of cookies.