Pharma consulting | 医療用医薬品コンサルティング・市場調査 | インフォーマ・ファーマインテリジェンス

Pharma consulting(ファーマコンサルティング)では、経験豊富なコンサルタントが弊社のデータベース群をフル活用し、かつ、外部の情報ソースも利用してお客様のニーズに合わせた個別の市場調査・分析を行います。

コンサルティングで下記のニーズにお応えします：

自社パイプラインの確率調整済みNPVはどれくらいか？
市場参入時の競合状況はどうなるか？
競争が激しい分野の情報をタイムリーに追跡＆視覚化するためにどうすればよい？
承認を受けるための最良の臨床開発経路はどのようなものか？
より高い償還価格を実現するには、どのような治験のエンドポイントが役立つか？
ある製品にとって最良の臨床試験実施機関をどのように選ぶべきか？
臨床試験のための被験者募集に関する実現可能性とタイムラインはどの程度か？
開発中製品の上市までの時間、成功確率、商業的価値のバランスをどうとるか？

Pharma consultingご利用のメリットを1分間の動画にまとめました。ぜひご覧下さい。

インフォーマセミナー講演動画
Pharma consultingのシニアディレクター・Timothy Pangが、Pharma consultingサービスのケーススタディを交えて講演を行いました。
1. Bringing data alive: Consulting Case Studies(2018年2月／東京)
2. New horizons, fresh opportunities: Tech, Big Data, and the next pharma wave(2017年11月／東京)

Consulting enquiry

Medtech Insight: 世界の医療機器・医療技術の最新情報

New Device Tax Repeal Bills Are Coming, With Candidate Klobuchar's Help

By ferdous-al-faruque 14 Feb 2019

Despite a recent report that Sen. Amy Klobuchar, D-Minn., is backing away from leading efforts to repeal the medical device tax due to her presidential ambitions, sources say she is working with Sen. Pat Toomey, R-Pa., to cosponsor a repeal bill this year. Similarly, on the US House-side, Rep. Ron Kind, D-Wisc., is calling on his colleagues to support a full repeal bill as well.

Medtech Insight: 世界の医療機器・医療技術の最新情報

One In Three Medtech Innovators Will Be 'Driven Out Of Business' By EU MDR, German Business Survey Finds

By Ashley Yeo 14 Feb 2019

The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.

Medtech Insight: 世界の医療機器・医療技術の最新情報

BSI Touts Very Short Waiting Times For Migrating Certificates From UK To Netherlands

07 Feb 2019

With a growing urgency for medtech manufacturers to take decisive action so their products are not banned from the market under an increasingly likely no-deal Brexit, clients of BSI will be relieved to hear their notified body believes time is on their side.

Medtech Insight: 世界の医療機器・医療技術の最新情報

US Homeland Security: Stryker, BD Devices Pose Hacking Risk

By elizabeth-orr 07 Feb 2019

The US Department of Homeland Security National Cybersecurity and Communications Integration Center is warning of potential cybersecurity vulnerabilities in Stryker hospital beds and BD diagnostics equipment.

Medtech Insight: 世界の医療機器・医療技術の最新情報

MDSAP Is A Snap If Your Firm Follows Quality Systems Standard ISO 13485, Auditor Says

01 Feb 2019

NSF International's Brian Ludovico explains why device-makers that already follow international quality systems standard ISO 13485 shouldn't be nervous about taking part in the Medical Device Single Audit Program. Ludovico also shares MDSAP participation numbers and says firms should feel at ease knowing that the program's auditing organizations undergo a rigorous process to become recognized by the MDSAP Regulatory Authority Council.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Bumps In The Road As US FDA Tries To Catch Up From Shutdown

01 Feb 2019

The recently ended record-setting US government shutdown is not anticipated to have a long-term impact on US FDA device review times. But agency reviewers will face more 510(k) review deadline pressures than usual and may have limited availability for pre-submission meetings in the short term, one expert suggests.

Medtech Insight: 世界の医療機器・医療技術の最新情報

US Federal Courts Can Operate Until Jan. 31; Patent Office Faces Imminent Closure Under Shutdown

28 Jan 2019

Federal courts and the US Patent and Trademark Office will soon run out of funds that have allowed them to continue normal operations under the partial government shutdown so far.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Standards, Not Predicates Emphasized In Finalized Alternative 510(k) Pathway

By elizabeth-orr 23 Jan 2019

Despite pushback from industry, US FDA has moved forward with plans to establish a new alternative 510(k) pathway by finalizing a guidance document that describes the so-called “Safety and Performance Based Pathway” that emphasizes use of consensus standards instead of direct predicate comparisons.

Medtech Insight: 世界の医療機器・医療技術の最新情報

EU Beats Predicted Timelines And Appoints First UK Notified Body Against MDRl

23 Jan 2019

There had been warnings that the first notified bodies would not be designated by the European Commission until late July 2019, 10 months before the full application of the EU Medical Device Regulation. But now that BSI is the first notified body in the EU to be designated under the MDR, are things looking up?

Medtech Insight: 世界の医療機器・医療技術の最新情報

NZ To Replace Outdated And Piecemeal Device Rules

16 Jan 2019

There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.

Medtech Insight: 世界の医療機器・医療技術の最新情報

About Three Months Worth Of Carryover Device Fees Remaining FDAs Gottlieb Says

16 Jan 2019

US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.

Medtech Insight: 世界の医療機器・医療技術の最新情報

UK To Demand 'Responsible Person' Be Physically Located In Country Under No-Deal Brexit

10 Jan 2019

The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.

Medtech Insight: 世界の医療機器・医療技術の最新情報

2019 Will Be Testing Period For US FDAs Novel Pre-Cert Paradigm For Digital Health

By ferdous-al-faruque 10 Jan 2019

In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Global Approvals Infographic

07 Jan 2019

Meddevicetracker recorded 62 medical device approvals from outside the United States in the first quarter for 2018, including 46 CE Marks from Europe.

Medtech Insight: 世界の医療機器・医療技術の最新情報

EU Regulatory Roundup November 2018

05 Dec 2018

The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.

Pharma consulting: 医療用医薬品のコンサルティング

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Timothy Pang

Consultant, Senior Director- Pharma consulting

Richard Veal

Practice Lead, Global Director, Head of Pharma Consulting

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