Experience. Integrity. IMPACT.
What We Do

Before you file your IND…

March 14, 2018 | Preeti Chugha, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

You’ve determined that you need to file an IND to conduct human trials in the US. What do you need to do before you submit your IND? While INDs can be opened at any stage of product development, the main focus of this post is on pre-IND activities for those being submitted to support first-in-human studies.

Nonclinical and CMC activities

During a new drug’s early preclinical development, it is necessary to determine that the product will not expose humans to unreasonable risk when used in limited, early-stage clinical studies, and that it exhibits pharmacological activity that justifies commercial development. To that end, nonclinical and chemistry, manufacturing, and control (CMC) data should be collected to include in an IND and support the initiation of a clinical trial. These components of an IND include:

Continue reading

The Ins and Outs of INDs

February 16, 2018 | Kathryn Tworkoski, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Introducing a new therapeutic agent to human patients can be simultaneously exciting and nerve-wracking. Over the years, we’ve had a lot of questions about the best way to prepare for an Investigational New Drug (IND) submission. So we’ve decided to tackle those questions in a series of blog posts. In this introductory post, we’re going to focus on some background information that will help explain the overall purpose and requirements of an IND.

Let’s start with . . .

Continue reading

Tips for Effective Meetings – Getting the Most out of the Time Spent Together

December 20, 2017 | Elaina Howard, PhD, RAC, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services

Have you recently tried to schedule a meeting with your coworkers and found it difficult to find a time when everyone is available? If this is the case, then you know how precious the time together can be and how important it is to have effective and efficient meetings.

To put time spent in meetings into perspective, I often remind myself that while in a meeting, you are really using that time spent multiplied by the number of people in the room. That can be a lot of pressure to make good use of this time!

Not to worry, though; in this blog post, I’m going to suggest general meeting efficiency tips and I will also detail how I aim to get the most out of two common types of meetings for regulatory medical writers.

Continue reading

Why and How to Conduct a Strategic Review of Regulatory Documents

November 16, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing and Corporate Communications | Medical Writing Services

As regulatory medical writers, we are trained on how to write for regulatory audiences, but how often are a Sponsor’s project teams trained to review the regulatory documents we write? At IMPACT, our answer is – as often as possible.

We encourage our project teams, as well as our internal staff, to use strategic review practices whenever possible, to ensure an effective, efficient review. We have trained internal and external reviewers accordingly, both with excellent results.

In this post, we’ll share the keys for an effective strategic review of regulatory documents. Please consider following these tips during your next review and let us know how it goes!

Continue reading

RAPS Regulatory Convergence 2017: A Recap

October 11, 2017 | Mark A. Cierpial, PhD, RAC; Principal Regulatory Consultant | Regulatory Affairs

The Regulatory Affairs Professionals Society (RAPS) held another successful annual meeting (or “Regulatory Convergence” as it’s called) last month. This year’s Convergence was held at the Gaylord Resort at National Harbor on the DC Waterfront and offered more than 70 educational sessions presented by over 200 expert speakers from around the world. In addition, 135 companies, offering a wide range of regulatory services and solutions, were in attendance in the exhibit hall.

Continue reading