Post-Interphex Showcase: Outsourcing & Consulting Services

Pharmaceutical Analysis & Stability Programs
The BASi Pharmaceutical Analysis Group teams with the Stability Management Group to offer a complete package – from early stage API method development to post-commercialization product testing. Testing is in compliance with all cGMP and GLP regulations, and we welcome projects which are analytically challenging. We have an outstanding regulatory history, a strong technical staff and believe in scientist-to-scientist to communication every step of the way. Compendial, BASi-developed or client-supplied methods. See www.bioanalytical.com/pharm

BASi, West Lafayette, IN
www.bioanalytical.com
tel. 765.497.8458

Technical Training Courses
Enhance your knowledge and advance you career by attending one of Natoli's internationally recognized technical training courses. Industry professionals and Natoli?s highly experienced staff address valuable information that cannot be found in any textbook. "...I am leaving this seminar with more enhanced knowledge to do my job even better," -Compression Technician, KV Pharmaceuticals.2008 courses include: Pharmaceutical Tablet Technology, Validating Solid Forms in a GMP Compliant Manner and more to come.

Natoli Engineering Company, Inc.,Saint Charles, MO
www.natoli.com/
tel. 636.926.8900

Let Us Supply the Missing Piece
Whether you need consulting with Quality Systems, GMP compliance, microbiological/sterilization or laboratory services, LexaMed can help. We provide pharmaceutical, medical device, dietary supplement and biotechnology companies with quality, compliant, integrated services in consulting and laboratory support. Our team of experienced consultants and laboratory staff has been servicing industry for over thirty years helping companies meet regulatory expectations and reach business goals. We offer support in:Quality Systems Management;Equipment Qualification;Process Validation and Optimization;Microbiology;Aseptic Processing;Regulatory Compliance;Operational Effectiveness;Internal and External Audit Services;and CGMP Training Programs (multi-lingual).

LexaMed, Ltd., Toledo, OH
www.lexamed.net
tel. 888.232.5227

Pharmaceutical Program Management
ABC Laboratories is pleased to announce a new initiative aimed at supporting the drug development efforts of specialty, virtual, and other small drug development companies. The company's new Pharmaceutical Program Management unit will assist sponsors with study design and regulatory consulting services, and dedicates senior technical staff to provide oversight of operational performance, facilitate collaboration and ensure timely delivery. The service is headed by Patrick Noland, an industry veteran with 30 years of pharmaceutical research and manufacturing experience. Noland is a contributing author to the CMC sections of four approved NDAs, two of which were inhalation products approved in the first application round.

Analytical Bio-Chemistry (ABC) Laboratories, Columbia, MO
www.abclabs.com
tel. 573.443.9000

Pfizer CentreSource
Pfizer CentreSource (PCS), one of the world's leading suppliers of dosage form manufacturing and active pharmaceutical ingredients (APIs), draws upon the depth and breadth of Pfizer's world-class global manufacturing network to provide a broad range of complex sterile manufacturing capabilities and services, including: Product typesm sterile suspension solutions, lyophilized, potent, cytotoxic, ampoules, blow/fill/seal, pre-filled syringes; Development- and commercial-scale production; Full technology transfer, process optimization and validation; Batch production documents; Scale-up/validation batches; Packaging specifications; Material evaluations on raw/packaging materials; Stability testing; FDA pre-approval and inspection prep

Pfizer CentreSource, New York, NY
www.pfizer.com
tel. 269.833.4567