Warren G. Baker has been appointed chief executive officer of Pharmatech Associates, replacing Calvin Wong, Pharmatech’s founder, who will now serve as chairman of the advisory board. Mr. Baker, a 25-year medical device and healthcare technology veteran, will be responsible for driving the company’s business strategy and overall performance.
 
Mr. Baker joined Pharmatech in 2012 and brings more than 20 years of senior management experience, serving as CEO and COO in the medical device and information technology industries. He has expertise with QA/RA, marketing, sales, and production in international environments, including product certifications for international devices (Class II and III) through ISO (90001, 13485 and QSR), CE Mark certification, and with the FDA and Health Canada.
 
“To strengthen Pharmatech’s position as a premier global compliance consulting firm, we are making key hires in response to the needs of our customers and the global marketplace,” said Calvin Wong. “Warren’s extensive experience in medical devices, in biotech, and his track record as a leader of successful companies make him a perfect fit. I am delighted to have Warren on board and eager to continue our work together as we grow and provide services that improve patients’ lives.”
 
Also, Richard Aleman has been appointed vice president of Regulatory Compliance. Mr. Aleman, an international regulatory expert and 28-year veteran of the U.S. FDA, brings supervisory experience in the regulatory and enforcement arenas, with knowledge of the compliance issues confronting the drug, biologics, medical devices and dietary supplement industries.
 
At the FDA, Mr. Aleman worked in the field and at headquarters, focusing on biopharmaceuticals, drugs, and medical devices. His international experience includes assignments with the Food and Agricultural Organization of the United Nations (FAO), US AID, the World Health Organization (WHO), and the United States Pharmacopeia (USP), where he was lead auditor, as well as representing the FDA at conferences in Latin America, North America, and the Philippines. Mr. Aleman has also served as director of compliance for small to mid-size pharmaceutical companies, dealing with quality assurance, quality control and regulatory affairs.
 
“Pharmatech’s regulatory approach of achieving compliance through science aligns with the requirements of global regulatory authorities for quality and product predictability,” said Bikash Chatterjee, Pharmatech’s president and chief scientific officer. “Richard is an outstanding addition to our expert executive team in terms of FDA and international requirements, and our customers will benefit greatly from his wealth of insight.”