Services

POLICIES & PROCEDURES

We recognize the dynamic and complex challenges facing life science organizations – big and small – and strive to develop clear, structured, and accessible documentation to meet your specific compliance needs. We have a strong command of compliance laws, codes, and regulations and are skilled at clearly and concisely communicating key content.

Whether you are launching policies for the first time, looking to refresh existing documents, or seeking to improve operating performance, we can develop effective documentation that informs and engages your organization.

We help address your organization’s specific compliance needs by developing clear, structured, and accessible documentation that reaches your audience.

What We Do

Our commitment to our clients includes a comprehensive collaboration between our team of experienced professionals and your company’s representatives from Compliance and Legal. Together, we author and implement compliance documentation in alignment with all applicable federal, state, and company-specific laws and regulations.

Custom Content
However broad or specific your need, we offer expertise on a wide range of compliance topics. We deliver clear, concise content that reflects your company’s unique culture, content style, and design preferences.
Policy Simplification and Design

We help companies simplify policies and make them more accessible to an increasingly younger, mobile workforce. Thick policy manuals tend to be outdated and difficult to read, exposing your organization to potential violations. We simplify existing content, eliminate redundancies, and focus on the most critical messages. Our graphic design specialists bring policies to life in an engaging, easy-to-read format that is conveniently viewable on mobile devices.

Launch Pad
Our Launch Pad policies are the perfect foundations for companies seeking rapid implementation of policies and procedures in advance of their first drug or device approval. We’ve drafted more than 25 Launch Pad policies, as well as functional-specific Launch Pad manuals, using a standardized process that allows for easy customization to company-specific rules, criteria, and structure.
Clear Procedures and Job Aids

Procedures help document “how” a process should be performed. Our consultants are experts at developing efficient processes that eliminate wasted steps and resources. We then document these processes in a clear format to ensure roles, responsibilities, and timelines are clearly communicated.

COntacts

Adam Oakley

Senior Director

Adam brings expertise in policy simplification and design and works closely with our Consultants and Design Specialist to build concise compliance documentation and accessible communications.

Dan Koerner

Senior Director

Since 2008, Dan has developed and delivered custom content to life-science organizations in accordance with their specific compliance needs, design preferences, and cultural practices

McCulloch Cline

Senior Manager

McCulloch helps companies develop a wide range of policies and procedures across varying topics, applying his deep knowledge and expertise to help clients implement industry best practices.

Year in Review