Search Results for Outsourcing

Showing 1 – 15

BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics By Michael Mezher - Published 15 March 2017

The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Packaging

Tags: Mixing, Diluting, Repackaging, Compounding, Outsourcing Facilities, BIO, Pew

Strategies and Tactics to Successfully Outsource Regulatory Work By Bill Snyder - Published 15 March 2017

This article highlights key learnings, helpful approaches and recommendations on how to successfully outsource operation-based regulatory work. The author Includes tips on knowing the right work to be outsourced, setting expectations, selecting a supplier, overcoming internal resistance to outsourcing, contracting standards and invoicing.

Categories: Features, US, Business Skills

Tags: Outsourcing, Performance Metrics

GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders By Michael Mezher - Published 18 November 2016

A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain.

Categories: News, US, FDA, Communication, Drugs, Manufacturing

Tags: Drug Compounding, Outsourcing Facility, Government Accountability Office, GAO

New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities By Michael Mezher - Published 03 August 2016

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities.

Categories: News, US, FDA, Biologics and biotechnology, Prescription drugs, Manufacturing

Tags: Compounding, Compounded drugs, Outsourcing Facility, Draft Guidance

Regulatory Focus Recap: February 2015 By Janet Aker - Published 03 March 2015

A recap of Regulatory Focus feature articles published in February 2015 for your reading convenience.

Categories: Features, Africa, Korea, US, FDA, Drugs, Regulatory strategy, Submission and registration

Tags: outsourcing

FDA Announces all User Fees to be Paid by Pharma, Device Industries in 2015 By Alexander Gaffney, RAC - Published 01 August 2014

The US Food and Drug Administration (FDA) has now released all user fee amounts for the coming 2015 Fiscal Year, including fees for medical devices, pharmaceuticals, generic drugs, biosimilar drugs, drugs compounded at outsourcing facilities, animal drugs and generic animal drugs.

Categories: News, US, CBER, CDER, CDRH, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Submission and registration, Veterinary products

Tags: PDUFA, MDUFA, BsUFA, GDUFA, ADUFA, AGDUFA, Outsourcing Fee, User Fee, FDA User Fees, FY 2015 User Fees

Getting the Match Right By Jonathan Morse, RAC - Published 06 May 2014

Recognizing that consultants are not one-size-fits-all, clients who develop a framework to screen potential consultants before working together enjoy a greater likelihood of success later.

Tags: Regulatory Consultants, Outsourcing in Regulatory, Regulatory Outsourcing, Regulatory Contracting, Outsourcing, Perspective

In Unusual One-Two Punch, FDA Follows 'Extensive' Warning Letter With Safety Communication By Alexander Gaffney, RAC - Published 30 April 2014

Categories: US, FDA

Tags: MDR, Contracting, Outsourcing, QSR, Park Doctrine, warning letter, Latest News, medical device

Legal Considerations When Outsourcing: Hold on Loosely, but Don’t Let Go By Alan Minsk, JD - Published 30 April 2014

In 1981, the US rock band .38 Special sang "Hold on Loosely, But Don't Let Go." This song lyric about love also holds true when considering whether to outsource regulatory responsibilities.

Categories: Features

Tags: Risks of Regulatory Outsourcing, Outsourcing in Regulatory, Regulatory Outsourcing, Outsourcing

Debarred, Denied, Restricted? Legal Responsibilities in Outsourcing By Sharon DeGrove Bishop, RAC - Published 29 April 2014

Regulatory professionals frequently work with their supply chain colleagues to ensure all relevant documentation is provided for the export of goods from the country of origin. However, there are little-known US regulatory requirements with potentially significant administrative and criminal consequences for violation, and many manufacturers may not be aware of them.

Tags: Export Restrictions, Department of the Treasury, Department of State, Department of Commerce, Resricted, Outsourcing, Debarred, Denied, Export, Import, It's the Law

Considerations for Clinical Research Outsourcing in Effective Multinational Clinical Studies of Medical Devices By Karen Jaffe, MS, MBA, RAC - Published 10 April 2014

Categories: Features

Tags: Multinational Clinical Trials, Outsourcing Clinical Trials, CRO, clinical trials

FDA Guidance Sets up User Fee System for Pharmaceutical Compounders By Alexander Gaffney, RAC - Published 31 March 2014

Categories: US, FDA

Tags: Compounding User Fee, Outsourcing Facility, 503B, User Fee, Latest News, guidance

Transforming Temporary Resourcing into Strategic Resourcing By Jennifer Thayer, MBA, MA, EdM, and Jason Falchuk - Published 26 March 2014

This article shares some tools for temporary resourcing the authors have leveraged over the years that can be helpful for hiring managers as well as individual contributors.

Tags: Regulatory Outsourcing, Hiring in Regulatory, Temporary Resourcing, Regulatory Careers, Perspective

Adding External Resources to Global Teams By Rosalie Cull, PhD - Published 14 March 2014

This article provides a perspective on the inclusion of regulatory consultants and contractors in global pharmaceutical product development and commercialization teams.

Tags: Outsourcing Regulatory Affairs, Regulatory Affairs Consulting, Regulatory Contracting, Regulatory Consulting, Perspective

Report: Outsourcing of Regulatory Services Rising Dramatically By Alexander Gaffney - Published 11 May 2012

Tags: Tufts Center for the Study of Drug Development, Outsourcing, Latest News, study, PDUFA, regulatory