Pharmatech Announces Key Hires and New Structure to Support Growth Initiative

 

Bikash Chatterjee Named President and Chief Scientific Officer

HAYWARD, Calif.—January 27, 2015—Pharmatech Associates has appointed Bikash Chatterjee to the position of President and Chief Scientific Officer (CSO). Mr. Chatterjee served as the company’s Chief Technology Officer where he established the Pharmatech Ecosystem™ as the company’s design for its four distinct consulting service offerings.

As Chief Scientific Officer, Chatterjee will be responsible for growing the company’s consulting services through its four spheres of technical expertise: Validation, Product and Process Development, Regulatory, and Compliance.

Pharmatech announced the following additions to their Senior Leadership Team:
– Wai Wong, Vice President, Validation. Mr. Wong brings 20 years of equipment, facility and process validation experience in the pharmaceutical, medical device, and biologic industries. Wong has earned an international reputation for expertise in Validation having demonstrated success in navigating the complex requirements of the FDA, EU and PIC/s compliance. Pharmatech was founded as a qualification and validation firm and Wong will continue to shepherd this practice area.
– Jorge Basso, Vice President of Product and Process Development. Mr. Basso brings 23 years of process and product design experience in the pharmaceutical, medical device, biologic and cosmetic industries, with expert knowledge of the key components of a successful product development program including compliance, regulatory strategy and validation.
– Richard Aleman, Vice President of Regulatory Compliance, a 28-year veteran of the U.S. Food and Drug Administration, 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. 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 we enter our third decade, Pharmatech’s growth strategy centers on our Pharmatech Ecosystem and deploying our Quality by Design and Quality Risk Management tools on behalf of our clients,” said Warren Baker, Chief Executive Officer, Pharmatech Associates. “Today, with engagements in the biotech arena, our work depends on understanding our client’s scientific foundations. Bikash’s contributions as Chief Scientific Officer will set new higher standards for our work as best-in-class service providers with a mission of compliance through science.”

“Pharmatech’s ecosystem is based on expert knowledge in all four practice areas at the leadership team level. Our team is exceptional in their knowledge of their specific practice areas and in the breadth and depth of experience in the life sciences,” said Bikash Chatterjee. “To remain competitive requires a complex mix of technical knowledge, practical business experience and broad regulatory compliance understanding, wrapped up in a culture of precise execution. That has been our recipe for success since 1995 and, as we enter our 20th year of business, it is the foundation for our future success.”

About Pharmatech Associates
Pharmatech Associates provides consulting and services to the regulated life science industry. Pharmatech’s services cover four spheres of technical expertise that are necessary throughout the complete product development lifecycle: Product and Process Development, Compliance, Regulatory, and Validation. This interconnected framework of services denotes the Pharmatech EcosystemTM. Pharmatech advises clients that range in size from startups to large multi-national corporations on projects in Asia, Europe and North America from its headquarters in the San Francisco Bay Area.
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Press contact:
Judy Curtis—SIPR for Pharmatech
+ 1 650-274-1509
judy@sipr.com

Pharmatech Associates Appoints Warren G. Baker as Chief Executive Officer

HAYWARD, Calif.—October 13, 2014—Pharmatech Associates today announced the appointment of Warren G. Baker as chief executive officer. Baker, a 25-year medical device and healthcare technology veteran, will be responsible for driving the company’s business strategy and overall performance in a period of high growth. Calvin Wong, Pharmatech’s founder and original CEO, will serve the company as chairman of the advisory board.

“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.”

“With the strong support of our founder, Pharmatech is expanding its technical team to focus on the Pharmatech ecosystem of Validation, Product and Process Development, Regulatory and Compliance,” said Warren G. Baker. “Calvin’s leadership has inspired the values we hold in our company culture. I look forward to working with him and our senior management team to help our customers improve their products and processes for better drugs and therapies that result in healthier populations worldwide.”

Warren G. Baker joined Pharmatech in 2012 and brings over twenty years of senior management experience spanning startup ventures and Fortune 100 companies, serving as CEO and COO in the medical device and information technology industries. He has functional 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.

 

About Pharmatech Associates

Staffed by industry experts, Pharmatech Associates (founded in 1995) provides consulting and services to the regulated life science industry. Pharmatech’s services cover four spheres of technical expertise
that are necessary throughout the complete product development lifecycle: Product and Process Development, Compliance, Regulatory, and Validation. Pharmatech advises clients that range in size from startups to large multi-national corporations on projects in Asia, Europe and North America from its headquarters in the San Francisco Bay Area. www.pharmatechassociates.com
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Press contact:
Judy Curtis—SIPR for Pharmatech + 1 650-274-1509
judy@sipr.com

Pharmatech to Present Quality by Design and Global Regulatory Compliance Topics at the 2014 ISPE Annual Meeting

HAYWARD, Calif.—October 13, 2014—Pharmatech Associates, a regulatory compliance consultancy serving companies in the pharmaceutical, biotech and medical device industries, will be presenting on a broad range of key topics including facility design and regulatory compliance, Quality by Design (QbD) and the new Process Validation (PV) requirements, at the 2014 International Society for Pharmaceutical Engineering (ISPE) Annual Meeting taking place October 12-15 in Las Vegas.

Bikash Chatterjee, Pharmatech’s President and CSO, will present four education sessions that demonstrate the benefits of new science-based quality- and design concepts and an approach for their practical application, based on Pharmatech’s global experience. The topics include: the Impact of the Drug Quality Security Act (DQSA) and Serialization Requirements; a Design Assessment Model for Pharmaceutical Drug Manufacturing Facilities; a Framework for Implementing QbD to Satisfy the New PV Guidance; and Securing Information as Part of the Global Supply Chain.

The ISPE Annual Meeting features presentations by more than 200 leading global pharmaceutical industry and regulatory experts, and give professionals an opportunity to engage in open dialogue for a better understanding of the industry’s current technical and regulatory challenges. Pharmatech Associates are available to meet at booth T92.

ISPE is the world’s largest not-for-profit society serving pharmaceutical and medical device, engineering, science and manufacturing professionals.

 

About Pharmatech Associates

Staffed by industry experts, Pharmatech Associates (founded in 1995) provides consulting and services to the regulated life science industry. Pharmatech’s services cover four spheres of technical expertise that are necessary throughout the complete product

development lifecycle: Product and Process Development, Compliance, Regulatory, and Validation. Pharmatech advises clients that range in size from startups to large multi- national corporations on projects in Asia, Europe and North America from its headquarters in the San Francisco Bay Area. www.pharmatechassociates.com

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Press contact:
Judy Curtis—SIPR for Pharmatech + 1 650-274-1509
judy@sipr.com

Pharmatech Hires Richard Aleman to Lead Regulatory Compliance

HAYWARD, Calif.—October 13, 2014—Pharmatech Associates today announced the appointment of international regulatory expert Richard Aleman as vice president of Regulatory Compliance. Aleman, a 28-year veteran of the U.S. Food and Drug Administration (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.

“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 CSO. “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.”

“What sets Pharmatech apart is this group’s ability to partner with its customers, based on their practical understanding of the product development lifecycle in every phase,” said Richard Aleman. “I look forward to helping Pharmatech become the undisputed leader in our field of endeavor.”

While at the FDA, Aleman worked in the field and at headquarters organizations, 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. Transitioning from government service to the regulated industry, Aleman served as Director of Compliance for small to mid-size pharmaceutical companies, dealing with quality assurance, quality control and regulatory affairs.

 

About Pharmatech Associates

Staffed by industry experts, Pharmatech Associates (founded in 1995) provides consulting and services to the regulated life science industry. Pharmatech’s services cover four spheres of technical expertise that are necessary throughout the complete product development lifecycle: Product and Process Development, Compliance, Regulatory, and Validation. Pharmatech advises clients that range in size from startups to large multi- national corporations on projects in Asia, Europe and North America from its headquarters in the San Francisco Bay Area. www.pharmatechassociates.com

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Press contact:
Judy Curtis—SIPR for Pharmatech + 1 650-274-1509
judy@sipr.com