About Us

Our Mission

Aseptria’s mission is to provide its customers with expert and reliable management of pharmaceutical outsourcing for CMC activities: formulation and process development, manufacturing, analytical testing and regulatory services.

 

Hector Tamburini, founder and President

Over 20 years in the pharmaceutical operations, with technical expertise in manufacturing of injectable and oral products.  Proven record of interaction with contract providers and regulatory authorities, and CMC project management.

As head of contract manufacturing at IDEC Pharmaceuticals / Biogen Idec for injectable drug products, Hector managed the manufacturing of the commercial Zevalin^®, Tysabri^® and clinical products as anti-CD23, anti-CD80.

Previously, Hector worked for Roche in the quality and manufacturing groups.  He headed the manufacturing of injectables, oral liquids and tablets, as well as packaging of worldwide brand products as Bactrim^®, Rochephin^® and Valium^®.

Hector headed several CMC teams from initiation to IND filing, coordinating activities of development, manufacturing, quality, regulatory affairs and other groups. 

 

CMC Subject Matter Experts

Aseptria has access to a vast network of professionals and service providers, all with proven track record in their areas of expertise within the following areas:

· Formulation development

· Drug substance / API manufacturing

· GMP Compliance

· Quality Control and Quality Assurance

· Drug product manufacturing

· Packaging and shipping

· Regulatory affairs for CMC submissions

Phone: (760) 525-3168

To contact us:

E-mail: info@aseptria.com

6431 Kiwi Place

Carlsbad, CA 92011-3608

Pharmaceutical Outsourcing Management- Consulting