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
- Clinical trial oversight
- Clinical trials
