Biologics

Regulatory affairs is RCA’s 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
• Clinical Development
  • eClinical Research Organization (CRO) Sourcing
• Analytical Development
  • Bioassay Design & Validation
  • Immunoassay Support
  • Statistical Analysis & Specification Setting

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, RCA biotech consulting global team can help.

• Assessments
  • cGMP, CAPA, Investigations & Deviations
  • Data Integrity & Quality System Gap Assessment
• Preparation, Training & Inspection Readiness
• Audits
  • Internal, Supplier CRO, & cGLP
  • cGMP Compliance: Manufacturing, Pilot Plant, Laboratory

RCA’s 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. Consultants are Quality experts with experience spanning start-ups to international corporations. 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

RCA 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, RCA biologics consultants have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees. Is widely recognized for its ability to help companies successfully resolve complex regulatory challenges. Our value goes beyond the initial response by helping companies execute their plans. Our unique expertise and experience make partnering with us a competitive differentiator in the remediation space.

• 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 Equipment & Processes
  • Remediation of System Deficiencies Related to, Manufacturing Process, Equipment, or Facility
  • Facility Improvements (Aging Facilities)

Whether it’s a strategy, technical plan, or project, RCA’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.

• Manufacturing Optimization & Aging Facilities
• New Product Development
• Product Life Cycle Management
• Staffing Support
• Mergers & Acquisition / Due Diligence