Founded in 2020 in Barcelona with staff with more than 20 years of experience in development and commercial manufacturing of bulk and finished products in USA and Europe in Biotech industries. Purpose: To generate a positive impact in Biotech startup companies looking to implement and manufacture quality products and services. Our services are: 1. Professional On site training or Webinars on topics like, - Current Good Manufacturing Practice for Finished Pharmaceuticals. - Quality Control in Biotech and Pharma Industries - Topics in Quality Assurance of Biopharmaceuticals - Data Integrity - Investigation of Out of Specifications and Out of Trending in a QC Laboratory - Automation of Analytical Methods in Biotech Industry among others Training are also offered as part of Masters in Pharmacy, Regulatory and Quality Assurance among others. 2. Career Coaching of young professional who wish to venture in the private regulated sector of biopharmaceutical industry or medical devices. 3. Specialized Mentoring and Consulting, - Implementation of Quality Management Systems (e.g. ISO 13485). - Quality Control Laboratories Design, Implementation and Management including Talent Acquisition of Specialized personnel. - Writing and Validation of Laboratory Procedures. - Technology Transfers (e.g. R&D to Operations, QC). - Management of Equipment Controls and Qualifications. - Data Integrity of Operations. - Internal & External Auditing. - FDA regulations and expectations. - Registration of Facilities and Products with Spanish Health Agency. - Management and Approval of Manufacturing License from Spanish Health Agency. - Analysis of Key Performance Parameters in QA & QC. - Generation and Validation of Standard Operating Procedures. - Laboratory Investigations in regulated industry per FDA guidelines. - Talent Acquisition of QC & QA Specialized personnel Our values are Quality, Customer Service, Empathy, Trust & Respect.
