SACC San Diego’s Biotech and Life Science Program

San Diego is known for its large and vibrant Biotech industry and prestigious research institutions, such as UCSD, Scripps and Burnham Institute. SACC’s Life Science group in San Diego include industry leaders, quality and regulatory affairs experts, pharmaceutical and medical device sales and marketing professionals, entrepreneurs and academic researchers. Our network of biotech and pharmaceutical regulatory affairs strategists, quality control and manufacturing experts covers the globe and can be called upon for special projects.  We can help Life Science companies, large and small, with the tasks listed below and more. 

The Swedish American Chamber of Commerce San Diego can also be of assistance if you wish to establish a bridgehead in the USA for, e.g., manufacturing or sales and marketing activities. Our internal resources can handle many issues independently, but we can also connect you with specialists in our network in areas outside our own capabilities.

Examples of tasks and services SACC San Diego and our Life Science network can provide:

Chemistry Manufacturing and Controls (CMC)
Develop plans for analytical method development, validations, specifications appropriate to each stage of development, preparation of CMC sections of regulatory submissions, response to questions

Package Qualification (Extractables and Leachables)
Extractables are generated under extreme conditions using for example, model solvents of high eluting strength, high temperature and high and low pH. Leachables are chemical entities that migrate from the container closure system and/or other packaging components under recommended conditions of product use and storage. Studies must be conducted in support of regulatory applications for licensure.

Regulatory Strategy
Develop strategic regulatory plans and prepare for FDA and EMEA meetings.

Risk analysis and risk management
Provide proactive means to identify and control risks during development and manufacturing and improve decision-making when problems arise.  Minimize risk to product and thereby to patient.

Quality systems
Perform GAP analysis, improvement plans, develop robust quality systems, training, and mock inspections.

For information, please contact:

Nils U. Olsson, Ph.D. 
SACC San Diego Board Director of Life Science

Contact Nils