Latest news from Syntagon

October 2012
Carina Svensson - a distinguished regulatory CMC expert joins Syntagon.

Syntagon is proud to announce that Carina Svensson - an distinguished expert in CMC and regulatory affairs has joined Syntagon as a Director of Quality Assurance and Regulatory CMC.
Before this appointment Carina was a Associate Director Regulatory CMC at the Global Regulatory Affairs AstraZeneca. Besides her regulatory experience Carina has 10 years of hands-on experience in process development.
"We are very excited to see Carina among our experts. Carina's experience will help us to better understand the needs of our customers and thus provide higher levels of service across the areas of drug development."

September 2012
Meet Syntagon in Madrid

Syntagon will be exhibiting at CPhI (ICSE) in Madrid, Spain on October 9-11th.
Do you need help with developing your drug candidate to clinical trials? Get an advice on IMPD or IND submission and preparation of CMC documentation package? Or talk face-to-face about an ongoing project?
Or maybe simply stop by to say hello? We are in Hall 8 Stand H38.
More on CPhI.

August 2012
George Köllner discusses ICH Q9 - Quality Risk management

What does ICH Q9 - Quality risk management say? Read an exclusive article by world-class quality expert George Köllner.
Click to read full article (PDF)

 

April 2012
Syntagon looking for highly experienced, dedicated person to lead quality control group.


Following its restructuring program Syntagon is looking for a highly experienced and dedicated person to lead its quality control and analytical development group. The perfect candidate would have a Ph.D. in analytical chemistry with at least 5 years of experience from pharmaceutical, biotech or CRO/CMO environment; would spend large part of time working "hands-on" in the lab; have a strong focus on chromatographic method development and MS detection for small molecules and preferably biopolymers;  an ability to provide problem solving skills on scientific and technical levels is also required.
The responsibilities involve direct contact with the customers thus the candidate is expected to be service-minded and possess strong communication and reporting skills.
Experience in working in a GMP environment will be considered as an advantage.
Please send your application (CV and cover letter) to andis.slaitas@syntagon.com with subject line 'Job application'.
 
For more information regarding the vacancy please contact Mattias Forsgren (Mattias.Forsgren@syntagon.com +46 707498337)
 
 

January 2012
Syntagon enters a collaborative agreement with world class QA expert George Köllner

 

We are very happy to announce a great addition to our QA and regulatory team: Syntagon has entered a collaborative agreement with George Köllner – a world class Quality Assurance expert. George brings more than 20 years of experience from pharma industry. George has held a position of Director of Quality Assurance at AstraZeneca where his major focus has been leading the development and implementation of modern Quality Assurance systems in API Process Development.

”I am very excited having George on our team, it will allow us to better serve our customers by strategically setting the quality levels best suited for the project and thus avoiding costly delays”, says Ulrika Burén, Syntagon QA Officer.

In addition to serving the GMP projects George’s expertise will also be available as a stand-alone service – from quality consulting to setting up internal quality systems and performing external audits.
We are confident that this addition will strengthen our strategic direction of an improved service quality at Syntagon
 

Syntagon offers higher quality service

Syntagon is very excited about being able to increase the level of quality it provides.

We see that the regulatory requirements for clinical materials are becoming more demanding, and we see more and more later stage - Phase II and III projects, which are more quality demanding. Our approach is simple – we at Syntagon will do what we have always done – we will put our customer’s needs first, and we will restructure our company to increase the levels of quality of services we provide.

Our Swedish site will focus on regulatory support and quality assurance as well as customer relations and project management. The plant where the products are manufactured and the manufacturing support team will also remain in Sweden. In Latvia we will focus on clinical development of production methods for drug substances, quality control and preclinical supply.
The result of these changes will be a significant increase in the quality of services and we will be able to provide this quality at the same price as today.