In today’s environment, medical device and pharmaceutical manufacturers are seeking alternate solutions to handle key functional areas such as Pharmacovigilance, Product Complaints and Medical Information.  Implementing and maintaining these programs internally carries significant time, cost and resource burdens. 

 

regulatory complianceWith increased scrutiny by regulators, Pharma Outsourcing provides a flexible solution with the ability to scale up or down quickly based on the needs of the business.  Furthermore, research performed by Grand View Research indicates that there will be a significant increase in outsourced activities by the year 2025. 

 

Some of the benefits that companies can expect to see from pharma outsourcing and pharmaceutical staffing agencies include:

 

  • Increased focus on core competencies
  • Improved processes and increases in efficiency
  • Ability to scale up / down quickly
  • Accelerated oversight control
  • Improvements in compliance
  • Leveraging of internal resources on other projects
  • Decrease in operational costs

 

Outsourcing Implementation Assessment and Strategy

Outsourcing key functional areas allows a company to focus on the core competencies of their business.  We can assist with pharma outsourcing and evaluating if consultant talent is right for you by performing:

  • Evaluation of Existing Program – Review of the current state of the program to gain a better understanding by reviewing the following areas:
    • Management Hierarchy
    • Operational costs of existing program
    • Staffing
    • Systems
    • Operational Logistics
  • Strategic Planning Session – After review, RCA Subject Matter Experts (SMEs) will meet with key stakeholders to discuss our strategy findings and next steps.
  • Development and Structure of the Future State program
    • Biopharma outsourcing
      • Pharma R&D outsourcing
      • Pharma Chem outsourcing
    • Software testing outsourcing
      • Software QA outsourcing
      • Agile QA outsourcing
      • Application testing outsourcing
      • Mobile testing outsourcing
    • Quality outsourcing
      • QA outsourcing

Upon completion of the assessment and strategy session, Regulatory Compliance Associates® will work with your team and the selected Partner to develop a communication model.  An area of key importance in a successful Pharmaceutical Outsourcing implementation is Collaboration, Commitment and Change Management.  We refer to these as the 3 Cs and we will work with your organization to address the points noted below.

 

Collaboration

  • Extensive collaboration is critical amongst the functional core team. All teams will be empowered and motivated to deliver success
  • Selection of the “right” leaders within the Client and Outsourcing Partner is critical in building strong team dynamics
  • Focus by Senior leadership on cultural and process change

Commitment

  • Key business Stakeholders are thoroughly engaged through the entire implementation
  • Transparency between teams builds mutual trust as well as appropriate and timely resolution
  • Open lines of communication to provide constructive feedback for continuous improvement

Change Management

  • Specific and timely communication is critical
  • Knowledge and focus on the long-term strategy and big picture must be the leadership motivation and SME’s to get through the challenges that will occur during implementation.

Since 2000, medical device, pharmaceutical and biologics manufacturers around the world have trusted Regulatory Compliance Associates® as their go-to consulting firm. Our team of over 500 industry experts offers the hindsight and advantage necessary to give you clear guidance from beginning to the end of the product life cycle. No matter what your unique industry needs, count on Regulatory Compliance Associates® to develop an ideal consulting solution tailored to help you comply with industry regulations and meet your goals.

 

About RCA’s Pharmaceutical Consulting Services

regulatory complianceRegulatory 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, Regulatory Compliance Associates® offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process. 

 

Client Solutions

 

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

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

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

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates®, we offer the experience and resources necessary to guide you in quality compliance.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

Quality Assurance

 

Regulatory Compliance Associates® Quality consulting services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

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

 

Remediation 

 

Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.

 

We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, Regulatory Compliance Associates® can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA

regulatory complianceRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

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 FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due 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®.

 

regulatory complianceSotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, 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 more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory 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. 

 

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