ÃÛ¶¹ÊÓƵ

Please note that functional cookies must be enabled to listen to a podcast.

In this episode of RCA Radio, host Erika Porcelli and guest Steve Cox, a ÃÛ¶¹ÊÓƵ Compliance Associates (RCA) Senior Consultant, cover the business strategy of outsourcing surveillance in both the medical device and pharmaceutical industries. Not recognized as a business strategy until the late 1980’s, outsourcing is now looked at as a strategic partnership for businesses, growing increasingly in the U.S. with many key considerations at play.

Listen in as we discuss a brief history of business process outsourcing and its impact on the U.S. labor market, functions primary to an outsourcing strategy and the traits they share, the steps and timeline necessary to outsource a workflow, the pros and cons to this strategy, potential change paradigms that could arise, and regulatory considerations.

 

About RCA’sÌýPharmaceutical Consulting ServicesÌý

 

ÃÛ¶¹ÊÓƵ Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, ÃÛ¶¹ÊÓƵ Compliance Associates^® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the ÃÛ¶¹ÊÓƵ Compliance Associates team knows the unique inner workings of the regulatory process.Ìý

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, ÃÛ¶¹ÊÓƵ Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

• Companies new to FDA, Health Canada or EU regulations and regulatory compliance
• Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
• Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
• Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

ÃÛ¶¹ÊÓƵ Affairs

 

ÃÛ¶¹ÊÓƵ affairs is ÃÛ¶¹ÊÓƵ Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of ÃÛ¶¹ÊÓƵ Affairs, from ÃÛ¶¹ÊÓƵ Support for New Products to Life Cycle Management, to other services like Outsourced ÃÛ¶¹ÊÓƵ Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

• New Product Support
• Product Lifecycle
• Other ÃÛ¶¹ÊÓƵ Services
• Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At ÃÛ¶¹ÊÓƵ Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

• Assessments
• Audits
• ÃÛ¶¹ÊÓƵ Agency Response
• Preparation and Training
• Inspection Readiness
• Data Integrity

 

Quality Assurance

 

ÃÛ¶¹ÊÓƵ Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. ÃÛ¶¹ÊÓƵ Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

• 21 CFR Part 11
• Data Integrity
• Manufacturing Support
• Facility Support
• Quality Metrics

Ìý

Remediation ServicesÌý

 

ÃÛ¶¹ÊÓƵ Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

ÃÛ¶¹ÊÓƵ Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each ÃÛ¶¹ÊÓƵ Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

• ÃÛ¶¹ÊÓƵ Action
• ÃÛ¶¹ÊÓƵ Compliance
• ÃÛ¶¹ÊÓƵ Enforcement
• Warning Letter
• 483 Observation
• Oversight Services
• Risk Management Plan

 

About ÃÛ¶¹ÊÓƵ Compliance Associates

 

ÃÛ¶¹ÊÓƵ Compliance Associates^®Ìý(RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of , , and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatoryÌýdue diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

 

Sotera Health Company, along with its three best-in-class businesses – ,ÌýÌýandÌý, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the ÃÛ¶¹ÊÓƵ Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.Ìý