Our clinical and regulatory affairs team has extensive experience with small compounds, cell and gene therapies, biologics, and other areas. Together with our clients, we design thorough regulatory plans that guarantee the creation, assessment, and marketing of successful products. https://hubs.ly/Q02zMvht0
Pharmatech Associates, a USP company
Pharmaceutical Manufacturing
Hayward, California 3,546 followers
Pharmaceutical manufacturing expertise bring medicines to the market.
About us
Pharmatech Associates, a global consultancy for the life science industry, advises U.S. and global drug sponsors and manufacturers of quality medicines in many major markets. A wholly owned subsidiary of U.S. Pharmacopeia (USP) with expertise in small molecule, cell & gene therapy, biologics –monoclonal antibodies– and advanced manufacturing technologies. Services include product and process development, quality management, quality assurance, and product management. Pharmatech Associates helps clients navigate the regulatory landscape of the FDA and international health authorities and provides guidance for U.S. market entry. Pharmatech Associates serves clients ranging from start-ups to large multi-national corporations. The company’s multidisciplinary team of professionals are thought leaders with integrated knowledge across all areas of product development who bring industry experience to every engagement reducing time-to-market for their clients. One of Pharmatech Associates’ core strengths lies in strategic program development. Pharmatech’s team assists clients in navigating the regulatory landscape of FDA and international health authorities, helping them achieve and maintain compliance. This expertise is vital to success during product development, manufacturing, and commercialization phases, ensuring that clients meet stringent regulatory requirements while meeting business objectives and anticipating FDAs downstream requirements to reduce program risk. Pharmatech Associates guides clients by helping organizations implement robust quality management systems, conduct risk assessments, investigate deviations through thorough root cause analysis, determine CAPAs, and provide training to build competency and ensure compliance with industry standards.
- Website
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http://pharmatechassociates.com/
External link for Pharmatech Associates, a USP company
- Industry
- Pharmaceutical Manufacturing
- Company size
- 11-50 employees
- Headquarters
- Hayward, California
- Type
- Privately Held
- Founded
- 1995
- Specialties
- Product and Process Development, Regulatory Affairs, Regulatory Compliance, Filing & Publishing Support, Chemistry Manufacturing Controls, 510K, Pre Approval Inspection, FDA Design Controls, Quality Managment Systems, Quality Risk Management, Compliance Remediation, Operational Excellence, Tech Transfer, Analytic Methods and Validation, Facility Design, Process Optimization, cell and gene therapy, and mAbs
Locations
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Primary
Get directions
22320 Foothill Blvd.
Suite 330
Hayward, California 94541, US
Employees at Pharmatech Associates, a USP company
Updates
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Generic drug companies face multiple challenges when entering the U.S. market, including finding the right distribution partners and ensuring data integrity. Strategic planning and understanding the stringent regulatory requirements are critical to overcoming these barriers and capitalizing on the opportunities for growth. https://hubs.ly/Q02zMvcM0
Entering the U.S. Market: What Does it Take for Generics? | Home
https://pharmatechassociates.com
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Important aspects of plasmid DNA purity are explained in the new article "Assessing pDNA Purity For Cell & Gene Therapies" by our senior analytical consultant Brian Glass. The application of conventional development methods to the difficulties encountered in producing gene therapy products is examined in this article. Brian highlights the upcoming USP 1040 chapter and offers advice on developing successful control measures for plasmid DNA, a crucial building block in the industry. https://hubs.ly/Q02zMqzM0
Assessing pDNA Purity For Cell & Gene Therapies
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Compliance only is not enough to enter the U.S. pharma marketplace, a culture focused on quality is just as important. The significance of safety and transparency in the production and distribution of drugs is emphasized by the Drug Quality and Security Act, which also emphasizes the need for strong manufacturing procedures and product tracing systems. https://hubs.ly/Q02zMpTM0
Entering the U.S. Market: What Does it Take for Generics? | Home
https://pharmatechassociates.com
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Any pharmaceutical business hoping to get into the generics market has to understand the approval procedure of the U.S. Food and Drug Administration. Companies need to manage these regulations in order to succeed. An integrated approach to regulatory compliance can significantly streamline this daunting task. https://hubs.ly/Q02zMsh90
Entering the U.S. Market: What Does it Take for Generics? | Home
https://pharmatechassociates.com
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Wrapping up training with Asociación Mexicana de Laboratorios Farmacéuticos. Thank you to our kind hosts and the member companies for participating. #nearshoring #supplychain
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Pharmaceutical companies are changing as a result of continuous manufacturing, which incorporates control and real-time monitoring technologies into the manufacturing process. Adopting flexible analytical techniques early on maximizes output, reduces waste, and expedites the delivery of new products. What kind of technology integration are you doing? https://hubs.ly/Q02zMsh60
How To Unlock The Benefits Of Continuous Manufacturing
https://pharmatechassociates.com
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The demand for low-cost, high-quality drug offerings in the U.S. is high, with 6.3 billion prescriptions written annually and more than 300 drug shortages each year. This is good news for drug companies pursuing U.S. market entry, but where to start? Jorge Basso, Bikash Chatterjee, and Steve Schiltz are with Asociación Mexicana de Laboratorios Farmacéuticos member companies today teaching important considerations for participating in the US market.
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The U.S. market continues to be a profitable battlefield for generic medicine manufacturers. There is a considerable need for reasonably priced, superior generics, so businesses should weigh a product's marketability in comparison to its rivals as well as its approvability. https://hubs.ly/Q02zrRlK0
Entering the U.S. Market: What Does it Take for Generics? | Home
https://pharmatechassociates.com
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Pharmatech’s roadmap to U.S. market entry provides an end-to-end, integrated strategy that informs intelligent tradeoffs and a more cost effective, efficient path to FDA approval and U.S. commercialization. Asociación Mexicana de Laboratorios Farmacéuticos #nearshoring
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