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Claus Grunwald
Regulatory Affairs Manager at Kinsy
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Work Experience
Regulatory Affairs Manager
Feb 2016 - Present · 8 years and 11 months
Responsable De Calidad
Apr 2010 - Jan 2016 · 5 years and 9 months
audit gmp
Auditor Sistemas De Calidd Gmp
Feb 2010 - Sep 2010 · 7 months
Company Details
51-200 Employees
Kinsy is an independent CDMO, located in Spain, with over 30 years of experience. Our main activity is the development and manufacturing of advanced pharmaceutical intermediates and APIs. As a result of our size (around 100 people) our company has a fast, flexible and competitive response to customer’s enquiries, including: 1- Development of novel synthetic routes and analytical methods. 2- Optimisation of laboratory recipes to reduce isolation steps, improving yield and quality, and eliminate the use of toxic and dangerous reagents. 3- Scaling-up of laboratory recipes to pilot-plant. 4- Production of Kg quantities for clinical phase trials. Possibility of fast purification by flash chromatography. 5- Process validation and scaling-up to commercial scale production (up to >100 MT/yr). 6- Regulatory support: DMF and CEP submissions, REACH registration. At Kinsy, we prefer to talk about partners, rather than customers. Because we believe that good communication and personal contact are essential for a successful and long-term business relationship. We give a fast, clear and detailed response to any enquiry. Our partners are invited to visit our plant during any step of their project, with direct access to our responsible people and transparent information. Our aim is to work together with our partners to get the best quality product at lowest possible cost. Our company is accredited to the ISO 9001, international quality standards since 1996. Our working philosophy is based on cGMP, while keeping the flexibility of a small company. For APIs, cGMP certificate under inspection by Spanish Agency for Medicines and Sanitary Products (AEMPS) is available. Our company is currently audited by AEMPS and by many customers on a regular basis, including some of top-20 pharmaceutical companies in the world.
Year Founded
1991
Social Media
Linkedin
Industry
Chemical Manufacturing, Materias prima para la industria farmaceutica, Materiales a base de productos químicos, Industría química, farmacéutica y plásticos, Productos químicos de base para productos farmacéuticos según normas nacionales, Pharmaceutical raw materials to national standards, Chemical base materials, Chemicals, Pharmaceuticals & Plastics, Raw materials for pharmaceuticals
HQ Location
Avda. Europa s/n Parque Industrial de Alhama Alhama de Murcia, Spain, 30840, ES
Keywords
Development and scale-up of fine chemicalsProducts for clinical phase trialsCustom synthesis of pharmaceutical intermediates and APIsProcess and analytical method validationNew Chemical Entityand Drug Substance Manufacturing
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