Pharmaceutical Outsourcing Company Focus: A Russell Publishing Publication

COMPANY BACKGROUND

Date Founded 2006
# of employees 25
Annual Revenues Privately Held

Key Personnel

• Gregory Gonzales, President
• James Fife, Director, Manufacturing Operations
• Samuel Santiago, Director, Quality and Regulatory
• Chris Waldo, Project Manager

FACILITIES

Our Grand Rapids facility includes:
• 11,400 sq.ft.
• Class 100/ISO 5/Grade A Filling Suite
• Steam Sterilizer
• Formulation Suite
• Preparation Lab
• USP compliant WFI system
• BOC Edwards Lyophilizer with CIP capability
• Automated Vial Filler and Capping System

SERVICES & CAPABILITIES

Grand River APP is a parenteral contract manufacturer supporting new product development. With a state-of-the-art cleanroom and highly trained staff, Grand River APP provides small scale clinical trial materials aseptically filled into vials and lyophilization for the pharmaceutical and biopharmaceutical markets. Equipment
is capable of filling and capping 1 ml to 30 ml vials. Alternate container closure systems are filled in a semi-automated method. The Grand River APP facility is designed to service customers in development, Phase I, Phase II, Phase III clinical trials and small scale commercial production. In addition to sterile manufacturing, services include, product formulation, process development, analytical/microbiological testing, packaging and regulatory support.