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FDA Consultants & Regulatory Response Services

 

Every day, as pharmaceutical companies go about their core business of developing breakthrough medicines to save lives and improve the quality of life of countless patients, the regulations they must meet continue to develop. It’s understandable that regulatory challenges, such as a warning letter, can arise for any size of pharmaceutical company.

 

Root Cause

 

What may seem like a localized issue that concerns one facility can actually have worldwide repercussions since critical drug shortages can be the result of even temporary production delays and plant closures. So, when a regulatory response does arise, finding the root cause of the problem and correcting it in the most efficient manner possible is clearly a priority for the pharmaceutical company, its stakeholders and the patients it can potentially help.

 

But if a company doesn’t know where to look for the root problem or how to address the warning letter in an effective manner, it can lose precious time and the lifecycle of the product can be detrimentally impacted.

 

RCA is Where Strategy Meets Success

 

After more than 20 years of experience helping pharmaceutical companies successfully navigate the regulations of the FDA and other agencies across the globe, we not only know how to look for causes of regulatory issues, but we also know where they typically occur. Most importantly, we know how to formulate a regulatory response strategy to correct them.

 

Warning Letter

 

Interestingly, for drug manufacturers, the most common warning letter problems that can lead to drug shortages typically occur in the supply chain. This is why it’s such a prudent choice to work with the team here at Regulatory Compliance »ÆÈ˵¼º½. We offer tailored pharmaceutical compliance and regulatory services throughout every stage of a product’s lifecycle.

 

Compliance Consultants

 

At RCA, we have a team of over 500 subject matter experts — including FDA compliance consultants and regulatory affairs specialists — who are well-versed in the intricacies of the pharmaceutical industry as well as the FDA’s modus operandi. We’re skilled at providing tailored support services to correct any compliance or regulatory issues you face throughout every stage, from research and development to manufacturing and quality assurance.

 

FDA Regulatory

 

We have a long list of pleased regulatory response clients, including new startup companies facing their first FDA regulatory challenges, Fortune 100 multi-national organizations looking to increase their market share, and even law firms in need of regulatory expertise when faced with challenges such as warning letters, import bans, 483s or consent decrees. This means when you outsource to Regulatory Compliance »ÆÈ˵¼º½, you’re not just getting a quality consultant — you’re getting targeted talent that’s up to the task.

 

Regulatory Action

 

If you’ve received a Warning Letter from the FDA or Notified Body, Regulatory Compliance »ÆÈ˵¼º½ can develop a comprehensive program to address it and any other larger regulatory affairs challenges that may arise with your pharmaceutical product. We will provide a Project Management Professional (PMP) to lead the program, in addition to engineers with expertise in quality systems and manufacturing engineering to execute the program that coordinates with your resources.

 

FDA 483

 

Every situation is different and the program’s regulatory response plan may include aggressive but realistic milestones, as well as supporting tasks, and task dependencies. Many of our consultants have experience in FDA-regulated industries and have the expertise to assist you with:

 

• 483 Remediation
• Pharma Warning Letter Remediation
• Consent Decree Remediation

 

About RCA’sÌýPharmaceutical Consulting ServicesÌý

 

Regulatory Compliance »ÆÈ˵¼º½ (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 »ÆÈ˵¼º½^® 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 »ÆÈ˵¼º½ 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, Regulatory Compliance »ÆÈ˵¼º½ 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

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance »ÆÈ˵¼º½ 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, 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 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 »ÆÈ˵¼º½, 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 »ÆÈ˵¼º½ 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 »ÆÈ˵¼º½ 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

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Remediation ServicesÌý

 

Regulatory Compliance »ÆÈ˵¼º½ 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 »ÆÈ˵¼º½ 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 »ÆÈ˵¼º½ 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 »ÆÈ˵¼º½

 

Regulatory Compliance »ÆÈ˵¼º½^®Ìý() 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, 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 demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance »ÆÈ˵¼º½ scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.Ìý