webinar

Managing Challenging Submissions Webinar

Facing unexpected questions and issues during your submissions process? Learn what next steps to take in RCA’s webinar on Managing Challenging Submissions.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Managing Challenging Submissions Webinar

 

How to Deal with Unexpected Questions and Issues During Your Submission Process

Learn what next steps to take when unexpected questions and issues arise during your submissions process during this webinar on Managing Challenging Submissions.

In this one-hour webinar, you will learn how to:

  • Minimize the risk of receiving a RTA Notification, Deficiency List, and / or AI Letter
  • Respond to FDA communications regarding your submission
  • Facilitate discussions with the Lead Reviewer
  • Leverage recent FDA guidance documents and recognize FDA trends or themes that may impact your submission or review process
  • Solicit and engage cross-functional support with engineering, quality, and new product development teams

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides regulatory compliance consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

sotera healthSotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

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