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:

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

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Contact us to learn more about our regulatory compliance experts and how they can help

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