PRZOOM - /newswire/ -
Butler, KY, United States, 2009/02/04 - SRD’s emphasis on and experience within Puerto Rico’s regulatory environment allows its clients to operate efficiently and effectively - SRDAdvisoryGroup.com .
SRD Advisory Group, LLC (“SRD”) is pleased to announce that it has opened its newest office in San Juan, Puerto Rico. Among the consulting services that SRD provides its clients are:
• Product registration;
• Regulatory compliance—including legislative monitoring;
• Record keeping;
• SOP review—including license verification;
• Pre-inspection auditing.
Officially registered as a Puerto Rican business through the Department of State, SRD is also licensed as a Representative Agent with the Puerto Rico Department of Health. Under Puerto Rican law, any pharmaceutical company that does not have a physical presence in the country must have a Representative Agent to act on its behalf in any situation that may arise with product distribution (such as product recall, discrepancy in product inventory, suspected counterfeiting, etc.) Product distributors, however, cannot be designated as Representative Agents, as Agents are not permitted to engage in product storage or distribution.
SRD has already registered several hundred products in Puerto Rico for major pharmaceutical companies—and SRD continues to build confidence and credibility with the Puerto Rican government. The government agencies with which SRD works closely to achieve compliance initiatives are:
• Department of Health;
• ASSMCA (controlled substance agency);
• Drug Enforcement Agency;
• Food & Drug Administration.
“Even prior to opening our San Juan office, SRD has done considerable work in the Puerto Rican market,” said Sandra Daunt, SRD’s chief executive officer. “Therefore because we are familiar with both the cultural and bureaucratic idiosyncrasies in Puerto Rico, SRD is confident that we can become the premier Representative Agent in Puerto Rico.”
“SRD is the pharmaceutical industry’s solution to staying ahead of the often-changing regulatory environment in Puerto Rico,” Daunt concluded. “With our commitment to value, timeliness, responsibility, and providing skillful resolution to client challenges, SRD is an important resource and ally.”
For more information on SRD (srdadvisorygroup.com), or to speak with SRD about its services in Puerto Rico (and elsewhere), please contact us by phone or via email.