November 2, 2022 Regulatory Affairs

Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?

Read Blog Post
November 1, 2022 Life Science Consulting

Be Careful What You Ask For (Prior to Consent)

According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100),…

Read Blog Post
October 28, 2022 Life Science Consulting

ProPharma Group’s Dr David Crome to Act as Compliance Monitor...

From April 2022, the MHRA has been developing a pilot programme for…

Read Blog Post
October 26, 2022 Life Science Consulting

Your Vendor Audit Program: On-site or Remote / Virtual?

It is quite common that a sponsor company will outsource services to…

Read Blog Post
October 25, 2022 Regulatory Affairs

FDA Accelerated Approval Pathway: A Potential Missed Opportunity for Sponsors

The accelerated approval provisions of FDASIA in section 506(c) of the FD&C…

Read Blog Post
October 20, 2022 Life Science Consulting

Clinical (IMP) Drug Supply…It’s Complicated

Things to consider and how to ease the process IMP Supply Management…

Read Blog Post
October 19, 2022 Regulatory Affairs

What You Need to Know About Developing Vaccines

An unlikely beacon of hope from the otherwise disastrous Covid pandemic, may…

Read Blog Post
October 12, 2022 Regulatory Affairs

Prescription Drug User Fee Act (PDUFA) VII and Type D...

For those who have been awaiting Congressional reauthorization of PDUFA, the wait…

Read Blog Post
September 27, 2022 Regulatory Affairs

What You Need to Know About CBER Pre-IND Meetings

The FDA provides several opportunities to hold meetings with Sponsors to gain…

Read Blog Post

ビジネスには複雑な課題があります。ProPharma Groupは優れたソリューションを提供しています。

弊社は製薬企業様、バイオテクノロジー企業様、医療機器メーカー様とともに複雑な課題にチャレンジいたします。弊社の経験豊かな専門スタッフが製品ライフサイクルの全段階で薬事と開発が成功するようにお客様をサポートいたします。詳細はお問い合わせください。

業界で優位性を確保したいとお考えですか? 弊社が最新の競争力を維持するお手伝いをいたします。


すべてのフィールドが必要です。
送信で問題が発生しました。以下にエラーがハイライトされました。