TM

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

FDA Regulatory Compliance Advisors, Inc.

Over the years FDA has implemented various initiatives to foster pharmaceutical innovation, most notably since the Pharmaceutical cGMPs for the 21st Century was launched in August of 2002.


In September of 2004 FDA issued the guidance “PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance”  to enhance the consistency and coordination of FDA's drug quality regulatory programs, in part, by integrating enhanced quality systems approaches into the Agency's business processes and regulatory policies concerning review and inspection activities.


Most recently, in December of 2015, FDA published the draft guidance “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base”. Under this program, pharmaceutical companies can submit pre-submission questions and proposals about the use of specific emerging technology to the Emerging Technologies Team (ETT). The ETT will serve as the primary point of contact for companies that are interested in implementing emerging manufacturing technology in the manufacture of their drug products.  

SHOULD ​not be a choice

but a need

The current regulatory approaches were formulated to deal with uncertainties in manufacturing, safety and efficacy around drugs. This is because the Pharmaceutical Industry is not as innovative and efficient as other high tech industries. 

As a member of the original PAT (Process Analytical Technology) Team and FDA Office of Regulatory Affairs’ senior representative to the ETT,

Emerging

Technologies

has resulted in undesirable consequences for the Pharmaceutical Industry, the FDA, and ultimately, the patients, such as:

For FDA as well as for Industry,

The failure

to innovate

"The Efficient Production
of Quality Products"

  • Recalls and drug shortages due to quality issues often caused by deficient quality systems and unpredictable and poorly designed and understood processes.
  • High manufacturing cost.
  • Low efficiency and considerable waste.
  • Strong reliance on regulatory oversight.
  • Low factory/equipment utilization rate.

INNOVATION...

Rebeca Rodríguez, President FDA-RCA™, is uniquely qualified to help your company understand and take advantage of the programs FDA has implemented to foster innovation in your company and gain a leading edge over competitors while increasing the efficiency of your manufacturing processes and the quality of your products.