TM

“Combining science with regulatory knowledge for optimized systemic solutions.” ™ 

FDA Regulatory Compliance Advisors, Inc.

Biotechnology

The failure to address these challenges properly can result in missed opportunities for: 

Likely reductions in market share as licensing of biosimilars increases globally.

The need to innovate to increase manufacturing efficiency and industry competitiveness in a complex and often inconsistent international regulatory environment.

The lack of harmonization and complexity of international requirements for post-approval changes often become roadblocks to innovation and process improvements.

Balancing the need for outsourcing with the inherent product quality and regulatory risks.

The Biopharmaceutical Industry of today faces numerous challenges, such as:

"The Road to Innovation and Manufacturing Efficiency” ™

Get the help you need to navigate these challenges and many others from Ms. Rebeca Rodríguez, former FDA National Expert Investigator / FDA National Lead Instructor and FDA-RCA’s President. With 27 years of experience as a regulator, including at least 14 in the biotech area, and Certifications in Quality Engineering (American Society for Quality, Certified Quality Engineer since 1991) and Process Analytical Technology (PAT), Ms. Rodríguez has the knowledge and expertise to help your organization implement compliant and innovative approaches to biotechnology manufacturing that will give your company a competitive edge as your manufacturing efficiency and the quality of your products increase. 

  • Innovation,
  • Loss of revenue and market share,
  • Dry product pipelines,
  • An increased reliance on acquisitions and mergers,
  • Patients inability to afford Biotech drugs,
  • Product counterfeit,
  • Managed care and future state and federal purchasing strategies,
  • High manufacturing costs,
  • Low efficiency and considerable waste,
  • Strong reliance on regulatory oversight, and
  • Low factory/equipment utilization rate.