黄人导航

Strategic Consulting

Pharmaceutical Strategy

 

Whether it’s a corporate needs analysis, corporate growth/transformation strategy or due diligence/acquisition, Regulatory Compliance 黄人导航 (RCA) worldwide experience can help ensure a successful mix of top-notch advice and people so your Pharmaceutical strategy is on time, and on budget — and you’re never embroiled in a costly mistake.

 

As an industry leader in pharmaceutical strategy consultancy, our team has the exceptional knowledge and expertise to help you work through the challenges of pre- and post-merger integration and company growth. We offer a range of Strategic Consulting services for the Pharmaceutical industry, including:

 

Portfolio Management

 

Portfolio management allows you to determine which projects show potential and which should be abandoned 鈥 encouraging the review of all products across a portfolio to best make decisions that impact a broad product line. Regulatory Compliance 黄人导航 will help you evaluate your projects and investments using a range of portfolio management services, such as:

 

  • Needs analysis
  • Risk mitigation, partnerships and strategy alliance
  • Asset evaluation
  • Stage-gate governance
  • R&D portfolio prioritization

 

Pharmaceutical Manufacturing

 

Many companies fail to take time to evaluate their manufacturing processes and determine how these methods impact their bottom line. We’ll help you maximize your ROI, validate manufacturing automation and ensure compliance of aging facilities and equipment. Our services include:

 

  • Engineering, Procurement, Construction Management (EPCM)
  • Program analysis & risk assessments
  • Improvements in lab efficiency and throughput
  • Problem-solving solutions
  • Validation support for aging facilities
  • Cost and waste reduction solutions

 

Regulatory Due Diligence

 

Before you move forward with a merger and acquisition (M&A) deal, you need to have a clear understanding of the associated benefits and risks. Our expertise gives us unique insight as we critically evaluate a target company’s characteristics to ensure a good fit for your business. We offer M&A and due diligence solutions including:

 

  • Regulatory and quality due diligence
  • Personnel, facility and equipment assessments
  • Post-merger integration
  • Risk identification

 

Outsourcing & Staff Augmentation

 

Small and large companies alike deal with staffing problems at some point in their lifetime. Whether you’re experiencing a short-term staffing issue or an unplanned crisis affecting your entire business model, we’ll craft a solution specific to your most pressing needs during this time. Regulatory Compliance 黄人导航 pharmaceutical outsourcing services include:

 

  • Project management
  • Virtual support
  • Staff augmentation and temporary placement of unfilled positions

 

Change Management

 

Organizational changes due to FDA compliance or evolving business needs can significantly affect the way a business is run, and these changes should be supported through a standardized change management system (CMS). Regulatory Compliance 黄人导航 will help you implement a CMS after:

 

  • Supplier changes
  • Facility upgrades
  • Changes to address complaints or comply with standards
  • Cost reduction initiatives

 

About RCA’s听Pharmaceutical Consulting Services听

 

Regulatory Compliance 黄人导航 (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 黄人导航 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 Regulatory Compliance 黄人导航 team knows the unique inner workings of the regulatory process.听

 

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 黄人导航 will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and 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

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance 黄人导航 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 Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory 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 Regulatory 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 Regulatory Compliance 黄人导航, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

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

 

Quality Assurance

 

Regulatory Compliance 黄人导航 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. Regulatory Compliance 黄人导航 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. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

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

Remediation Services

 

Regulatory Compliance 黄人导航 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.

 

Regulatory Compliance 黄人导航 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 Regulatory Compliance 黄人导航 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.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance 黄人导航

 

Pharmaceutical StrategyRegulatory Compliance 黄人导航听(RCA) provides pharmaceutical consulting to the following industries for resolution of life science 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 , , and globally-regulated companies.

 

As your partners, Regulatory Compliance 黄人导航 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鈥檚 unwavering commitment to its mission, Safeguarding Global Health.

 

Sotera Health Company, along with its three best-in-class businesses 鈥 ,听听and听, 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 Regulatory Compliance 黄人导航 scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.听

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