For one Fortune 500 biotech company with a missing parts problem, RCA created a process that included build lists, SOPs with embedded color pictures, 3-D exploded diagrams for all set ups, and GMP documentation to show the process was in control. In short, RCA took a crisis and turned it into a best practice.

 

Regulatory Compliance Associates® Inc. can assist you in ensuring the quality of your biologics during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, we can shepherd your biologics through design, labeling, promotion, production, and testing.

 

Our Biologics services include:

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the biologics industry. Our 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® Inc. 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 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.

 

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

Remediation Strategy & Response

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 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 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

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