case study

Biosimilar Drug Development

RCA was requested to develop a regulatory strategy for a European based company engaged in biosimilar drug development, whereby they could seek approval for their drug in the US and EU. A major challenge was that the client wanted to utilize the data from a recently completed Phase III clinical trial conducted entirely outside the US and not under an IND. RCAs regulatory affairs team, confirmed that CDERs Office of Biotechnology would have jurisdiction. After reviewing all current FDA guidance, RCA proposed that the client request an initial advisory meeting as this would be their first contact with FDA.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Biosimilar Drug Development

Client Challenge

A European based company engaged in biosimilar drug development requested RCA to develop a regulatory strategy, whereby they could seek approval for their drug in the US and EU. A major challenge was that the client wanted to utilize the data from a recently completed Phase III clinical trial conducted entirely outside the US and not under an IND.

RCA’s regulatory affairs team confirmed that CDER’s Office of Biotechnology would have jurisdiction. After reviewing all current FDA guidance, RCA proposed that the client request an initial advisory meeting as this would be their first contact with FDA.

 

RCA Approach

The first hurdle to overcome was verification that clinical data met cGCP, cGMP and FDA regulations and guidance documents pertaining to Use of Foreign Clinical Data. Since the client did not originally intend to seek FDA approval, they adhered strictly to the EMA approach which is different.

 

FDA Regulatory

RCA supported the Client as they retrieved copious amounts of records and documents. Slowly, adequate documentation was sorted from that generated, to conform to EMAs similar but different requirements. When reconstructed, this documentation essentially met FDAs requirements for cGCP.

regulatory compliance

 

Biological License Application

The next hurdle was to pull together a briefing package on behalf of the client to support an Initial Advisory Meeting request. As the client was in the process of preparing a Biological License Application in Europe at the time, substantial Safety, Efficacy, Pharmacology and Bioanalytical data were available.

 

Reference Listed Drug

The client had substantial bioanalytical data comparing their biosimilar to the European marketed reference listed drug (RLD). Generation of comparative bioanalytical data that could be used to build a bridge, to the US RLD drug, was still on-going.

 

FDA Submission

RCA submitted an FDA briefing package on behalf of the client. FDA rejected the meeting request based on insufficient bioanalytical comparison data between the clients biosimilar and the US RLD. Over a four- month time period the client was able to generate additional bioanalytical comparison data to the US RLD.

 

FDA Meeting

RCA updated the original briefing package to include additional data and resubmitted another meeting request. This time the meeting request was granted. However, due to the extensiveness of the supporting data presented in the briefing package, FDA offered the option to the client to convert the advisory meeting into a BPD type II meeting request. As a result, the client saved a significant amount of time towards their goal of filing a BLA in the US.

 

Results

The outcome of the meeting request with FDA is being withheld at this time to maintain confidentiality for our client.

 

About RCA’s Biologics Services

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
  • 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® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex remediation services & challenges. 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 complianceRegulatory Compliance Associates® (RCA) provides regulatory compliance 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 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. 

 

 

Client Challenge

A European based company engaged in biosimilar drug development requested RCA to develop a regulatory strategy, whereby they could seek approval for their drug in the US and EU. A major challenge was that the client wanted to utilize the data from a recently completed Phase III clinical trial conducted entirely outside the US and not under an IND.

RCA’s regulatory affairs team confirmed that CDER’s Office of Biotechnology would have jurisdiction. After reviewing all current FDA guidance, RCA proposed that the client request an initial advisory meeting as this would be their first contact with FDA.

 

RCA Approach

The first hurdle to overcome was verification that clinical data met cGCP, cGMP and FDA regulations and guidance documents pertaining to Use of Foreign Clinical Data. Since the client did not originally intend to seek FDA approval, they adhered strictly to the EMA approach which is different.

 

FDA Regulatory

RCA supported the Client as they retrieved copious amounts of records and documents. Slowly, adequate documentation was sorted from that generated, to conform to EMAs similar but different requirements. When reconstructed, this documentation essentially met FDAs requirements for cGCP.

regulatory compliance

 

Biological License Application

The next hurdle was to pull together a briefing package on behalf of the client to support an Initial Advisory Meeting request. As the client was in the process of preparing a Biological License Application in Europe at the time, substantial Safety, Efficacy, Pharmacology and Bioanalytical data were available.

 

Reference Listed Drug

The client had substantial bioanalytical data comparing their biosimilar to the European marketed reference listed drug (RLD). Generation of comparative bioanalytical data that could be used to build a bridge, to the US RLD drug, was still on-going.

 

FDA Submission

RCA submitted an FDA briefing package on behalf of the client. FDA rejected the meeting request based on insufficient bioanalytical comparison data between the clients biosimilar and the US RLD. Over a four- month time period the client was able to generate additional bioanalytical comparison data to the US RLD.

 

FDA Meeting

RCA updated the original briefing package to include additional data and resubmitted another meeting request. This time the meeting request was granted. However, due to the extensiveness of the supporting data presented in the briefing package, FDA offered the option to the client to convert the advisory meeting into a BPD type II meeting request. As a result, the client saved a significant amount of time towards their goal of filing a BLA in the US.

 

Results

The outcome of the meeting request with FDA is being withheld at this time to maintain confidentiality for our client.

 

About RCA’s Biologics Services

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
  • 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® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex remediation services & challenges. 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 complianceRegulatory Compliance Associates® (RCA) provides regulatory compliance 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 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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