Reportlinker Adds Pharma and Medical Device Regulatory Affairs

NEW YORK, March 8 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Pharma and Medical Device Regulatory Affairs

http://www.reportlinker.com/p0181144/Pharma-and-Medical-Device-Regulatory-Affairs.html

Guarantee smooth approvals with a top-flight regulatory affairs team

Regulatory teams save time and money as they drive commercial and development goals forward. Build healthy relationships with - and receive clear direction from - regulatory agencies through early, consistent communication.

Immediately draw upon the expertise of more than 50 leading companies across the life sciences spectrum. Whether you're part of a large pharma or a medical device firm, you'll find pioneering methods for adapting to the current regulatory climate. Empower regulatory affairs in these main areas:

Structure

Gain greater influence in the design, planning and direction of product development. Organize your team to solve problems more quickly - choose from innovative regulatory affairs structure models.

Communication

Consult timeline and frequency metrics to adjust your communication tactics with regulators. Along the way, explore novel strategies for engaging regulatory agencies - and absorb tailored recommendations specific to pharma and medical device firms.

Budgets and Staffing

Equip your team with the resources to generate the best possible product support. Spending and staffing benchmarks will guide you through resource allocation. Also, track outsourced activities and funding to understand why teams use vendors - and how much they spend on them. 

Companies Featured in this Report

Abbott Labs

Alcon Labs

Allergan

AngioDynamics

Archimedes Pharma

Ariston Pharma

AstraZeneca

Aritech

Bausch & Lomb

Becton Dickinson

Beckman Coulter

Biogen Idec

Bristol-Myers Squibb

Cardio3 BioSciences

Centocor

Corventis

Davol

DuPont

Fleming Pharmaceuticals

Fresenius Medical Care

Genzyme

GlobeImmune

GlaxoSmithKline

Haupt Pharma

Hoffmann-La Roche

Hospira

Jazz Pharmaceuticals

Johnson & Johnson

MedImmune

Medrad

Medtronic

Merck & Co.

Merck KGaA

MiddleBrook Pharmaceuticals

Novo Nordisk

Oasmia Pharmaceutical

Ortho-Clinical Diagnostics

Otsuka Pharmaceutical

Peregrine Pharmaceuticals

Pfizer

PLIVA

Roxane Laboratories

Sovereign Pharmaceuticals

Stryker

Suneva Medical

Tokai Pharmaceutical

Welch Allyn

ZARS Pharma

... and more

Chapter 1: Integrating Regulatory Affairs with Product Development

Regulatory affairs structure (dedicated department, arranged by therapeutic area or other)

Breakdown of structure by company type

Reporting relationships by company type

Position leading regulatory affairs

Organizational charts

Organizational charts showing regulatory intelligence structures

Chapter 2: Communicating with Regulatory Agencies

Reasons for lengthening timelines over the past three years

Factors having the greatest impact on regulatory affairs over the past three years

Frequency of contact with regulatory agencies by company type

Chapter 3: Regulatory Affairs Staffing and Budgets

Staffing

Percentage of companies that outsource some portion of regulatory affairs work

Change in regulatory affairs staffing: 2007 to 2010

Average increase in FTEs by company type: 2007 to 2010

Average number of FTEs dedicated to regulatory affairs by company type

Average FTEs per regulatory affairs position by company type

Differences in drug and device regulatory systems

Number of FTEs dedicated to regulatory affairs - broken out by company type

Percentage of companies' regulatory affairs departments that maintain a dedicated budget

Budgets

Breakdown of departments funding regulatory affairs at companies with non-dedicated budgets

Average regulatory affairs budget by company type

Responding companies' regulatory affairs department responsibilities by activity

Companies' regulatory affairs budgets - broken out by company type and by activity

Affairs department responsibilities by activity

Average budget per activity across all companies

Percentage of average budget per activity across all companies

Average budget per activity for companies that conduct the activity

Average percentage of budget per activity for companies that conduct the activity

Funding level changes since 2007 - also broken down by company type

Comparison of regulatory budgets by company type: 2007 to 2010

Average increase in regulatory affairs budgets by company type: 2007 to 2010

Average percentage Increase in regulatory affairs budgets by company type: 2007 to 2010

Outsourcing

Regulatory outsourcing percentage by company type

Percentage change in regulatory affairs outsourcing by company type

Average regulatory affairs outsourcing budget by company type

Average percentage of regulatory affairs budget dedicated to outsourcing by company type

Outsourcing challenges by category: small companies (mid-size, large, all pharma, medical devices)

Breakdown of outsourced regulatory affairs activity

To order this report:

Pharmaceutical Industry: Pharma and Medical Device Regulatory Affairs

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