Services: Other Services

For Biologics, Combination Products and Compounding Pharmacies

Regulatory Due Diligence

At Regulatory Compliance Associates, our team of experts help investors make better pre-acquisition decisions by executing regulatory due diligence, evaluating revenue expansion, and cost saving opportunities to help determine a target’s transaction value.

 

Due Diligence 

 

Previous clients have recognized Regulatory Compliance Associates® for offering the same investigative exercises that guide a Private Equity firm toward the proper judgment about proceeding with acquisition and how to negotiate the best deal price. We appreciate a refined approach to deal making and can you’re your entire deal team through each stage of the deal flow.

 

Regulatory Compliance Associates can help your team develop an integrated FDA viewpoint that lets Healthcare buyers develop a sensible viewpoint of the true story beyond the balance sheet. The regulatory due diligence benefit to your team is we’ll show you the asset value of what you’re buying, both tangible and intangible.

 

 

Regulatory Due Diligence

 

Environmental, Social, and Governance (ESG)

 

Environmental, social, and governance (ESG) investing is a set of standards used by socially conscious investors to conduct due diligence. Regulatory Compliance Associates has supported clients from around the world with their ESG programs and due diligence requirements. As sustainable investing continues to become more important in modern society, our regulatory consulting Experts can help you understand how to validate your environmental social governance strategy.

 

Further, the compliance process outlined in your environmental social and governance requirements can be accelerated by the due diligence consultant expertise Regulatory Compliance Associates provides. These are examples of ESG consulting services that RCA provides for global life science clients.

 

Social

  • Supplier Quality Assessment
    • Do your suppliers follow the corporate ESG standards set by your company?
  • Compliance Assessment
    • Are workplace conditions for employee health & safety currently compliant with ESG guidelines?

 

Environmental

  • Gap Assessment 
    • Does your company use accurate and transparent compliance processes for an ethical supply chain?
  • Internal Audit
    • Is your company accountable for following the mission & vision communicated to shareholders or investors? 

 

Governance

  • Change Management Assessment
    • How likely are your employees to pursue integrity during the product development or manufacturing process?
  • Transparency Assessment
    • Would your employees truthfully participate in a corrective and protective action (CAPA) program?

 

Since 2000, thousands of companies across the world have trusted Regulatory Compliance Associates® to care for their unique regulatory compliance needs. Our expertise is backed by more than 500 professionals, including FDA veterans and other subject experts who are here to guide you through every step of the regulatory compliance process. Whether you’re a Fortune 100 company or a small enterprise, trust Regulatory Compliance Associates to partner with you to tailor an ideal compliance services solution.

 

 

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. 

Additional Services

Regulatory Compliance Associates has the healthcare consulting experience and insights to guide Biologics through their entire lifecycle. We help companies navigate complex regulations for Combination Products to increase their successful launch and steer Compounding Pharmacies down the complicated path of compliance.

Biologics

Regulatory Compliance Associates® can assist you in ensuring the quality of your biologics or biosimilar product during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, our Biotech consulting experts can shepherd your biologics through design, labeling, promotion, production, and testing. Our Biologics consultants & consulting services include:

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates®  backbone and we fully understand the complexities of the biologics industry. Our biotech consulting expertise spans all facets and levels of Regulatory Affairs, from early phase & bioanalytical sciences through late phase and post approval.

 

  • Preclinical & CMC Consulting
    • FDA Meetings & Briefing Package Assistance
    • Clinical Trial Applications
    • Marketing Applications
    • Medical Writing
  • Lifecycle Management
    • Combination Products
  • Submission Planning & Strategic Support
    • eCTD Publishing & Submissions
  • Strategic Consulting & Intelligence
    • Risk Management Plan
  • US Agent
  • Project Management Support
    • Data Integrity
  • Clinical Development Support
    • Clinical Research Organization (CRO) Sourcing
  • Analytical Development Support
    • Bioassay Design & Validation
    • Immunoassay Support
    • Statistical Analysis & Specification Setting

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s biologics consultants preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® biotech consulting global team can help.

 

  • Assessments
    • Current Good Manufacturing Practice (cGMP)
    • Corrective & Preventive Action (CAPA), Investigations & Deviations
    • Facility & Maintenance 
    • Data Integrity
    • Quality System Gap Assessment
    • Quality Metrics
  • Audits
    • Supplier Audits
    • CRO Audits
    • cGMP Compliance Audits: Manufacturing, Pilot Plant, Laboratory
    • cGLP Audits
    • Good Clinical Practices
  • Preparation, Training & Inspection Readiness
    • cGMP Fundamentals (Annual Training Required by Regulations)
    • Quality System Regulation
    • Risk Management
    • Investigations, Deviations & CAPA & Root Cause Analysis
    • Validation & Technology Transfer
    • Purchasing Controls & Supplier Management
    • Document Management & Change Control
    • Audit Readiness
    • Quality Culture & Management Responsibility
    • Data Integrity & Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error

 

Quality Assurance

 

Regulatory Compliance Associates® Quality consulting services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics. Our biologics consultants goal is to ensure continuous improvement, aligning with your business needs and goals. Our biotech consulting subject matter experts have 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.

 

  • Quality Management System Implementation
  • SOP Development
  • Document Control Systems
  • Change Control
  • Laboratory Operations & Control

 

Remediation Strategy & Response

 

Regulatory Compliance Associates® is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, Regulatory Compliance Associates® biologics consultants have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
    • 483 Response & Remediation
    • Warning Letter Response & Remediation
    • Consent Decree Response & Remediation
    • Oversight Services
  • Consulting
    • Comprehensive Audits
    • Remediation Plan Development & Implementation
  • Manufacturing Support
    • Re-validation of Existing Equipment & Processes
    • Remediation of System Deficiencies Related to, Manufacturing Process, Equipment, or Facility 
    • Facility Improvements (Aging Facilities) 

 

Strategic Consulting

 

Whether it’s a corporate needs analysis, corporate growth / transformation strategy or due diligence / acquisition, Regulatory Compliance Associates®  worldwide biotech consulting experience can help ensure a successful mix of top-notch advice and people so your engagement is on time, on budget, and you’re never embroiled in a costly mistake.

 

  • Portfolio Management
  • Mergers & Acquisitions / Due Diligence
  • Staffing Support

 

Biostatistics

 

At Regulatory Compliance Associates, we recognize that biostatistics continues to change life science consulting one project at a time. Our biostatistics consultant Experts can help with both your internal or external clinical study and medical research needs.

 

RCA biostatisticians will create a custom scope of work based on the applicable statistical tests and predictive techniques that increase regulatory compliance. In fact, our statistical consulting team approach to clinical study design and clinical research provides Regulatory Compliance Associates clients a true competitive advantage during product development and commercialization. 

 

Our biostatistics consulting services include:

 

  • Clinical research
  • Medical research
  • Epidemiological research
  • Disease occurrence research
  • Disorder prevalence research
  • Data safety monitoring
  • Adverse event research

 

Regulatory Compliance Associates healthcare consulting Experts can provide quantitative analysis that propels your commercialization projects faster and more accurately. Our statistical consulting Experts can provide deep insights into the regulatory compliance process of what can help you with your regulatory submission.

 

Biostatistics is more than just getting your white paper published – it’s about saving lives and getting the right products to market. RCA’s epidemiological consulting team will provide a custom scope of work based on your clinical research studies. For over 20 years we’ve partnered with clinicians, PhD’s, MD’s, and epidemiologists to increase the success of their initiatives, including clients from:

 

  • Hospitals and health care systems
  • Government agencies and departments
  • Academic and university research programs
  • Life science manufacturers and organizations
  • Private equity and venture capital

 

Regulatory Compliance Associates biostatistics consulting team provides a diverse set of healthcare consulting services during the clinical research trials process, including:

 

  • Biostatistics
    • Clinical trials
      • Phase 1 clinical trial
      • Phase 2 clinical trial
      • Phase 3 clinical trial
      • Phase 4 clinical trial
    • Medical trials
      • Clinical trial oversight
        • World wide clinical trials
        • Decentralized clinical trial
        • Randomized clinical trial
        • Clinical test oversight
        • Pragmatic trial
        • Open label studies

 

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. 

Lessons Learned from Combination Products

Download our Free Combination Products Poster

This “Lessons Learned from Combination Products” poster was presented at the Parenteral Drug Association’s (PDA) Annual Meeting. Learn about the what, when, and how in accelerating new combination product development and regulatory pathways—in light of the recently finalized guidance: Good Manufacturing Practices for Combination Products.

 

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. You may also email us at [email protected].

 

Combination Products

Navigating the evolving, complex sea of regulations for Combination Products can be confusing and leave you with uncertainties. Strategic product development, coupled with an effective regulatory submission framework, increases the likelihood of a successful and timely launch of Combination Products.

 

Regulatory Compliance Associates® has developed an eight-step strategic regulatory plan for Combination Products:

 

  1. Define the Combination Product / Constituent Parts / Primary Mode of Action (PMOA)
  2. Prepare a Preliminary Regulatory Strategy
  3. Submit a Pre-Request for Designation (Pre-RFD)
  4. Update the Regulatory Strategy based on FDA’s Preliminary Informal, Non-Binding Designation
  5. Submit a Request for Designation (RFD)
  6. Update the Regulatory Strategy based on FDA’s Formal, Binding Designation Letter
  7. Early Collaboration Meeting with Lead Agency Center / Pre-Submission (PreSub) Meeting
  8. Submit Marketing Application(s) to Lead Agency Center

 

Support for your Combination Products

 

Regulatory Compliance Associates® has the expertise to see you through the entire lifecycle of your Combination Products. Count on us to support you with:

 

  • Development and Design Validation
  • Product Assessment and Request for Designation (RFD Submissions)
  • Global Regulatory Strategies
  • Agency Briefing Packages and Meeting Execution
  • Chemistry, Manufacturing, and Controls (CMC) and Clinical Data Support
  • Quality Systems Development and Support
  • Product Submissions (NDA, IND, ANDA, BLA, IND, 510(k), and PMA)
  • Electronic Common Technical Document (eCTD) Publishing and Electronic Submission
  • Inspectional Readiness
  • Training for Modified Quality Systems
  • Life Cycle Management and Post Approval Support
  • Due Diligence Audits / Mergers and Acquisitions

 

Understanding the Rules for Combination Products

 

The rules for Current Good Manufacturing Practice (cGMP) Requirements for Combination Products were issued by the FDA in 2013. Existing Quality Systems can stay in place, but new requirements are necessary for the components not already addressed. This is where Regulatory Compliance Associates® can support your team in various scenarios:

 

When adding a Device to Existing Drug or Biologic Product:

  • Design controls apply when a device constituent part is used in a combination product
  • Corrective and Preventive Actions (CAPA) process required
  • Management responsibility must be clearly identified

 

When adding a Drug or Biologic to a Device Product:

  • Need incoming materials and Release Testing
  • Expiration Dating and Stability Testing are required
  • Calculation of Yield must be included
  • Component, container-closure, and tamper-evident requirements are added

 

Assessing Risk in Combination Products

 

Molecule manufacturers may be less familiar with medical device constituent parts, and even less familiar with the evolving FDA rules. As the guidance is better understood by inspectors, it’s important for manufacturers to keep up and understand the rules or the risk becomes greater. Regulatory Compliance Associates® can help you understand and thrive:

 

  • How to best assure compliance of products and effectiveness of the cGMP controls in light of the evolving regulatory landscape
  • Obtaining objective evidence for the Design History File (DHF) that the drug / biologic is appropriate for use with the device and vice versa (“Drug-Device Interactions”)
  • How to incorporate Risk Management throughout the product life cycle
  • How to effectively merge CAPA and Non-Conforming Materials processes
  • The current enforcement climate and changes in Agency enforcement focus

 

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. 

Biologics Info Sheet

Learn About our Expertise in the Biosimilar Industry

Whether you need support with Product Development, Formulation Development, Compliance Assurance, Clinical and Manufacturing Development, Guidance and Pathways for Biologic/Biosimilar Approval, FDA Briefing, or Application Submission, Regulatory Compliance Associates® can help.

We have a proven track record of success and can navigate the Biosimilar process with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. Our services highlighted in this handout include:

  • Regulatory Affairs
  • Product Development
  • Formulation Development
  • Quality Systems and Compliance
  • Clinical and Manufacturing Development

Regulatory Compliance Associates® Inc. can assist you in ensuring the quality of your biologics or biosimilar product during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, our Biotech consulting experts can shepherd your biologics through design, labeling, promotion, production, and testing. Our Biologics services include:

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates®  backbone and we fully understand the complexities of the biologics industry. Our biotech consulting expertise spans all facets and levels of Regulatory Affairs, from early phase & bioanalytical sciences through late phase and post approval.

  • Preclinical & CMC Consulting
    • FDA Meetings & Briefing Package Assistance
    • Clinical Trial Applications
    • Marketing Applications
    • Medical Writing
  • Lifecycle Management
  • Submission Planning & Strategic Support
    • eCTD Publishing & Submissions
  • Strategic Consulting & Intelligence
  • US Agent
  • Project Management Support
  • Clinical Development Support
    • Clinical Research Organization (CRO) Sourcing
  • Analytical Development Support
    • Bioassay Design & Validation
    • Immunoassay Support
    • Statistical Analysis & Specification Setting

 

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® biotech consulting global team can help.

  • Assessments
    • Current Good Manufacturing Practice (cGMP)
    • Corrective & Preventive Action (CAPA), Investigations & Deviations
    • Facility & Maintenance 
    • Data Integrity
    • Quality System Gap Assessment
  • Audits
    • Supplier Audits
    • CRO Audits
    • cGMP Compliance Audits: Manufacturing, Pilot Plant, Laboratory
    • cGLP Audits
    • Good Clinical Practices
  • Preparation, Training & Inspection Readiness
    • cGMP Fundamentals (Annual Training Required by Regulations)
    • Quality System Regulation
    • Risk Management
    • Investigations, Deviations & CAPA & Root Cause Analysis
    • Validation & Technology Transfer
    • Purchasing Controls & Supplier Management
    • Document Management & Change Control
    • Audit Readiness
    • Quality Culture & Management Responsibility
    • Data Integrity & Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our biotech consulting subject matter experts have 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.

  • Quality Management System Implementation
  • SOP Development
  • Document Control Systems
  • Change Control
  • Laboratory Operations & Control

 

Remediation Services

Regulatory Compliance Associates® is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

  • Regulatory Action
    • 483 Response & Remediation
    • Warning Letter Response & Remediation
    • Consent Decree Response & Remediation
    • Oversight Services
  • Consulting
    • Comprehensive Audits
    • Remediation Plan Development & Implementation
  • Manufacturing Support
    • Re-validation of Existing Equipment & Processes
    • Remediation of System Deficiencies Related to, Manufacturing Process, Equipment, or Facility 
    • Facility Improvements (Aging Facilities) 

 

Strategic Consulting

Whether it’s a corporate needs analysis, corporate growth / transformation strategy or due diligence / acquisition, Regulatory Compliance Associates® Inc.’s worldwide biotech consulting experience can help ensure a successful mix of top-notch advice and people so your engagement is on time, on budget, and you’re never embroiled in a costly mistake.

  • Portfolio Management
  • Mergers & Acquisitions / Due Diligence
  • Staffing Support

 

About RCA®

 

Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the 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 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®.

 

Sotera 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.