Creation of Calibration, Validation & Research, Inc. (CVR)
With an investment of over $1 million, ReComS has created the first metrology laboratory of its kind in Puerto Rico, distinguishing itself from other laboratories by integrating six (6) distinct dimensions under the same roof, providing calibration and validation services for the market, not only in Puerto Rico, but also the Caribbean. CVR, incorporated in 2006 and having as its director one of the few metrologists in Puerto Rico, has installed its primary metrology laboratory close to ReComS Laboratories, in the Industrial Zone in Humacao. CVR will offer its calibration services to the industry in Puerto Rico and Latin America using primary standards for the temperature measurement, mass, pressure, force, dimension, and electrical areas. CVR has acquired equipment that is one of a kind in the island, such as the “super-thermometer”.
The company’s strategic objective is, among others, to attain the market of the instrumentation that is being sent abroad to be calibrated, ensuring that the devices used for the measurements of operational parameters perform with the required precision and exactness. With this in mind, thermometers in Puerto Rico ordinarily sent to the United States can be sent to CVR’s metrology laboratory in Humacao. This guarantees the availability of the instrumentation at a lower cost with the high accuracy and quality that is desired.
Part of CVR’s operation will include a paperless electronic documentation system providing its customers trustworthy documentation. Our customers will have access to their documentation on-line at any time. CVR, along with the rest of the companies that are part of ReComS Group, is currently working to obtain the International Standard Organization (ISO) certification.
To summarize, CVR is number one in its class because:
- CVR provides in one operation a large spectrum of calibration and primary metrology services.
- CVR has equipment with the highest accuracy and precision available to serve the Puerto Rican and Latina American market.
- CVR’s personnel are accredited by the authorities that certify its professional field.
ReComS Group in the fast-track of development
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ReComS Laboratories has become the largest external laboratory in Puerto Rico
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ReComS Group receives grant for lab in Humacao
CARIBBEAN BUSINESS August 10, 2006, p.Q03
By JONATHAN MAY
After acquiring Accupharma’s laboratory facility in March 2005, the Regulatory Compliance Services (ReComS) Group has just secured a grant from the Puerto Rico Industrial Development Co. (PRIDCO) for necessary capital improvements. “Our upper management team has, with the help of the grant from Pridco, committed a minimum of $4 million to upgrade these facilities,” said Nidia Acevedo, vice president of operations for ReComS Group. “This 12,000-square-foot facility will become the first metrology lab in Puerto Rico. We hope to be finished with our upgrades sometime during the first trimester of 2007,” she added.
Acevedo is confident the metrology lab will transform the ReComS Group into a “one-stop shop” for pharmaceutical and biotechnology companies. “We hope this will make us the primary consulting and service company for companies in the life sciences industry. Our clients will not have to send tests to the U.S. for certification with our metrology lab,” she said.
ReComS Group is also working toward expanding operations to Costa Rica. “We are working to sign a contract with the government of Costa Rica to facilitate our partnerships with the life sciences companies there,” Acevedo said. “Costa Rican companies produce a lot of evasive medical devices and they are in need of our microbiological and calibration consulting and services to meet the strict U.S. regulations,” she added. Acevedo said ReComS Group expects to have finalized this expansion by the end of this year, months in advance of earlier estimates.
In addition to Altyma Pharma Services, ReComS Group’s operations in Costa Rica, the company consists of five companies. One, Regulatory Compliance Services Corp., works on verifying the quality assurance of products and services to comply with companies and regulatory agencies’ standards. Calibration Validation & Research Inc. takes care of most of its customer’s validation and calibration projects that seek to reduce costs and maximize productivity.
Acevedo is also proud of an award ReComS Group received this year. “We are thrilled to have been given Johnson & Johnson’s Supplier Diversity Award for 2006,” she said. She added that ReComS Group competed against other small businesses on a national level for this award. “This award is an indication of our well-trained and qualified employees, our expansion into Latin America and our top-notch, high-tech equipment,” she added.
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ReComS Group to go after Latin American market
Consulting firm to open facilities in Costa Rica; Local operations to be expanded throughout the island
CARIBBEAN BUSINESS July 20, 2006, p. 22
By: DENNIS COSTA PACHECO
Locally based consulting firm ReComS Group wants to make it to the big leagues, with plans to open new facilities in Costa Rica that will significantly expand the firm’s client base in the Latin American market. The company has also increased its services and talent pool, effectively splitting its operations into five units to become a one-shop solution alternative for food, drug / medical device, cosmetic and healthcare companies.
Although ReComS (which stands for Regulatory Compliance Services) has been known primarily as a validation firm, Nidia Acevedo, vice president of operations of ReComS Group, said the company has adopted many other services, among them resources / business management, security and legal consulting, into its portfolio.
ReComS Group’s five companies include Regulatory Compliance Services Corp., which works on guaranteeing quality assurance of products and services to comply with companies and regulatory agencies’ standards. Calibration Validation & Research Inc. takes care of the majority of validation and calibration projects that seek to reduce costs and maximize productivity.
ReComS Laboratories Inc., which has just celebrated its first anniversary, is established in Humacao on the former site of AccuPharma Research & Scientific Consulting Inc. Meanwhile, Microbiological Media Manufacturing Co., which manufactures products used for the culture and identification of bacteria and fungi, will be in a building under construction near the laboratory facilities in Humacao. The company is also planning to establish installations in the western area of Puerto Rico to further expedite its operations.
Altyma Pharma Services Inc. will become the company’s presence in the international marketplace, with the establishment of offices in San José, Costa Rica. According to Arturo Cherena Jr., vice president of strategic development, the company already has a list of more than 20 clients waiting for the offices to begin full operations. Even though all companies are already working, Cherena expects them to be at 100% working capacity by January 2007.
ReComS talent, which totals close to 140 employees on the island, also includes a network of defense and regulatory lawyers that specialize in industry-related matters, including Acevedo herself, who has combined a bachelor’s degree in microbiology with postgraduate studies in law.
With this expansion, ReComS Group seeks to become a one-shop solution for companies that are forced to make adjustments in certain departments when production volumes are low. “We offer our resources to the companies when they need it, becoming in effect an extension of the company during the time that is necessary, which in the end is more cost-effective,” explained Acevedo, although she clarifies that they don’t become a permanent fixture in the company, just a solution that can be kept within the company on a temporary basis.
ReComS clients have included Johnson & Johnson, Novartis and Medtronic. Revenue figures for 2005 approximate $15 million, a dramatic increase from initial figures in 2003, which totaled roughly $1 million in revenue. Now, with the establishment of offices overseas and rapid expansion, Acevedo and Cherena acknowledged the sky is the limit for the upstart firm.
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ReComS certified as minority business enterprise
CARIBBEAN BUSINESS September 29, 2005, p.13
By CB STAFF
Regulatory Compliance Services Corp. (ReComS) now is certified as a minority business-enterprise supplier by the Puerto Rico Supplier Development Council (PRSDC), announced ReComS Chairman & CEO Eric Olivieri. ReComS has been a regulatory, security, and legal consulting firm to the food, drug, cosmetic, and healthcare industry in Puerto Rico and Latin America since 2003. As a PRSDC member, ReComS will be matched to more than 3,500 corporate members interested in purchasing goods and services from the National Minority Supplier Development Council network.
ReComS acquires Accupharma Research & Scientific Consulting
Regulatory company adds cleaning methods development and testing services
CARIBBEAN BUSINESS April 7, 2005, p.12
By MARIALBA MARTINEZ
Local Regulatory Compliance Services Corp. (ReComS) recently acquired Humacao-based Accupharma Research & Scientific Consulting Inc., a pharmaceutical analysis and microbiological products cleaning methods development and testing company, for an undisclosed amount.
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ReComS bridges the gap between pharmaceuticals and regulatory agencies
CARIBBEAN BUSINESS January 29, 2004
By B.G. DOYLE
With the mission of helping companies in the food, drug, cosmetic, and healthcare industries establish better working relationships with federal, local, and European regulatory agencies, Regulatory Compliance Services Corp. (ReComS) opened its doors in May 2003 and already has a long list of clients. “I saw the need for a group of individuals who could help companies work with a regulatory agency on a specific issue and build a bridge for better communication,” said Eric Olivieri, vice president & treasurer of ReComS. “The only time many companies deal with these agencies is when there is an audit, which is usually an adversarial and intimidating event.” With offices in San Juan, Isla Verde, and Caguas, the firm offers a unique mix of specializations.
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2005’s shared-government philosophy affects manufacturing industry
CARIBBEAN BUSINESS December 29, 2005, p.32
By MARIALBA MARTINEZ
As 2005 began, Puerto Rico should have seen what was in store for the manufacturing industry when Gov. Aníbal Acevedo Vilá’s confirmation to his post had barely been certified days before the official inauguration. With a Popular Democratic Party governor and a New Progressive Party-controlled Legislature, the phrase “shared government” became a sort of mantra for those wishing to believe it could work.
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Manufacturing sectors meet with local, federal regulatory agencies
First time industry meets with regulatory agencies as a group
CARIBBEAN BUSINESS March 25, 2004
By MARIALBA MARTINEZ
Representatives from the pharmaceutical drugs, medical devices, contract manufacturing, cosmetic, and orphan products manufacturing sectors recently met in San Juan with federal and local regulatory agencies to discuss government laws and regulations during the Regulatory Industry Outreach Conference.
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Manufacturing industry has full agenda till summer
Political candidates likely to be paying attention to industry concerns
CARIBBEAN BUSINESS February 19, 2004
By MARIALBA MARTINEZ
This election year is starting off with a number of events that will shape political parties’ campaign platforms related to Puerto Rico’s manufacturing industry.
Regulatory Compliance Services’ (ReComS) 2004 Regulatory Industry Outreach Conference will take place March 3 at San Juan Marriott Resort & Stellaris Casino, announced ReComS Vice President Eric Olivieri. Members of the pharmaceutical, medical devices, cosmetics & consumer, food processing & packaging, and healthcare sectors will hear about contract manufacturing, orphan products development, laboratory controls, product counterfeiting, security & safety, recalls & regulatory action trends, and compliance issues regarding medical devices.
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Regulatory Compliance Services helps companies avoid regulatory problems
Seventy-five cents of every dollar spent on healthcare goods is FDA-regulated
CARIBBEAN BUSINESS July 24, 2003
By: MARIALBA MARTINEZ
Eric Olivieri, the former Johnson & Johnson PSGA director of compliance, is helping U.S. Food & Drug Administration (FDA)-regulated manufacturing companies meet quality control standards and avoid thousands of dollars in fines.
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FDA CORNER
October, 2004-FDA Talk Paper
"FDA Releases 2004 Produce Safety Action Plan" The Food and Drug Administration (FDA) announced today that the final 2004 Produce Safety Action Plan (the Plan) entitled "Produce Safety from Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption" is available at In 1998, FDA issued the GAP/GMP guidance document, entitled, "Guide To Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables"... For the remaining article go to http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01318.html
August 2, 2004-FDA Talk Paper
"Acting FDA Commissioner Outlines Priorities for Next Six Months "
At the National Press Club “Newsmaker Luncheon” today, Dr. Lester M . Crawford, Acting FDA Commissioner outlined the agency's priorities and important anticipated major actions in the next six months. He focused on Technology Development and Innovation, Modernizing the Health Care System through GMPs, Increasing Access to Important and Life-Saving Technologies and Patient and Consumer Protection and Education. “The next six months will be a critical period in which FDA plans to take important steps forward to strengthen public health and build on our accomplishments in the recent past,” said Dr. Crawford. Highlighted below are major actions Dr. Crawford outlined today...For the remaining article go to http://www.fda.gov/bbs/topics/news/2004/NEW01098.html
"FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico" The Food and Drug Administration (FDA) is warning the public about counterfeit versions of the drugs Zocor (simvastatin) and carisoprodol that were recently imported from Mexico by individual americans. Tests indicate that counterfeit Zocor did not contain any active ingredient and that the counterfeit carisoprodol differed in potency when compared to the authentic product. Carisoprodol is used in the treatment of painful musculoskeletal conditions and Zocor is a cholesterol lowering drug. The counterfeit versions were reportedly purchased at Mexican border town pharmacies and sold under the names Zocor, 400/mg, (Lot Number K9784, expiration date November 2004), and Carisoprodol, 350/mg, (Lot Number 68348A). Patients who rely on these counterfeit versions of the drugs could develop serious heart risks (with the counterfeit Zocor) or have insufficient pain relief (with the counterfeit carisoprodol).... For the complete article go to www.fda.gov
ReComS and Accupharma at the 77th PRMA Convention
June 2 – 5, 2005
The 77th Annual convention of the Puerto Rico Manufacturer's Association was held June 2-June 5, 2005 at the Wyndham El Conquistador Hotel and Resort. ReComS and Accupharma participated in all of the conferences and business discussions. They also served as Exhibitors with an interactive booth that helped spread awareness about the services provided by ReComS and Accupharma. There, representatives from the company were able to talk to clients about their new services and facilities. The convention was a true success.
ReComS Group acquires Accupharma
March 29, 2005
As part of the commitment to continue enhancing its compliance, resources/business management, security, and legal consulting portfolio of services in Puerto Rico, US and Latin America, Regulatory Compliance Services, Corp. (ReComS) has acquired Accupharma Research & Scientific Consulting, Inc. (Accupharma) located in Humacao, Puerto Rico. Accupharma is known for its analytical and microbiological product testing and cleaning methods development services for the pharmaceutical industry.
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