Our Perspective
Featured posts
19/05/2021
Applicant Orientation Meetings
(Part 3) Applicant Orientation Meetings – Rigorous preparation is critical. We provide objective, strategic advice on the likely FDA review issues.
12/05/2021
Applicant Orientation Meetings
(Part 2) What is the purpose of an AOM? In this post we will cover the basics.
05/05/2021
Applicant Orientation Meetings
(Part 1) PharmApprove has a long track record of alerting our clients to the potential for an Applicant Orientation Meeting (AOM) - and helping tea...
26/03/2021
Value Communications and Negotiations – are you prepared?
Our consultants discuss the importance of adapting the regulatory data package and argument for approval to a payer audience.
18/11/2020
Team Spotlight: Dr. Steffen Thirstrup
Our consultants discuss the importance of adapting the regulatory data package and argument for approval to a payer audience.
27/09/2020
Importance of Excellence in Scientific and Regulatory Communications
A number of potential pitfalls await companies with even the most solid science and robust datasets.
18/09/2020
Proactive planning and communication with FDA is critical to regulatory success
It’s common knowledge that communicating early and regularly with the FDA is critical to regulatory success.
31/08/2020
Team Spotlight: Dr. Frank Casty
Introducing Dr Frank Casty a pulmonary/critical care physician with over 25 years of experience in the pharmaceutical industry.
07/08/2020
FDA Advisory Committees During COVID-19: When Face to Face is Not an Option
COVID-19 has made preparing for FDA advisory committee meetings more intense. The good news is that there are things you can do to set yourself up...
27/07/2020
Remote Q&A: Developing the perfect technique
Public speaking has become, well — less public. It’s been relegated to our home offices, with scripted presentations, glossy slides and even “appea...
18 September, 2020
Proactive planning and communication with FDA is critical to regulatory success
It’s common knowledge that communicating early and regularly with the FDA is critical to regulatory su...
8 September, 2020
Leveraging Expedited Regulatory Pathways to Optimize Drug Development
Webinar: Join us on Thursday 24th September 2020, 15:00 BST | 16:00 CEST | 10:00 EDT
31 August, 2020
Team Spotlight: Dr. Frank Casty
Introducing Dr Frank Casty a pulmonary/critical care physician with over 25 years of experience in the...
7 August, 2020
FDA Advisory Committees During COVID-19: When Face to Face is Not an Option
COVID-19 has made preparing for FDA advisory committee meetings more intense. The good news is that th...
27 July, 2020
Remote Q&A: Developing the perfect technique
Public speaking has become, well — less public. It’s been relegated to our home offices, with scripted...
15 July, 2020
Remote FDA Advisory Committee Meetings: Prepare for the Worst and Bring your Best
If you logged in for the first product approval-related virtual FDA Advisory Committee meeting yesterd...
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