Press Release
PharmaDirections Introduces Novel Electronic Batch Record for Clinical Trial Manufacturing
CARY (NC) – December 14, 2005 – PharmaDirections has introduced a first-of-its-kind, cGMP compliant electronic batch record for Phase I and II clinical trial manufacturing (CTM). In parallel, the complete CTM solution offers pilot-scale ‘virtual manufacturing’ of APIs, solid dosage forms, topicals, and parenterals. A pharmaceutical or biotech company can deploy our CTM electronic batch record including SOPs for their pilot plant.
- Improve quality – digital process control and audit trail with electronic signatures
- Remote access – anywhere, anytime access for the whole team, formulations, QA/QC, manufacturing, management
- Quick data access – save time by searching the database in seconds and generating reports at a touch of a keyboard
- Preserve capital – EBR (electronic batch records) ready for technology transfer to production system
- Regulatory compliant – validated, 21 CFR Part 11 compliant system with version control
For virtual pharmaceutical companies and small to mid-sized biotech and pharmaceutical companies, our ‘virtual manufacturing’ is an ideal choice. PharmaDirections and our virtual manufacturing customers are using the CTM electronic documentation system to integrate the development process from drug formulation to Phase II batch manufacturing. The manufacturing is performed in PharmaDirections managed cGMP pilot plants.
- ‘Instant GMP manufacturing’ – start today with no capital cost
- Complete solution – single source for software, SOPs and manufacturing
About PharmaDirections:
PharmaDirections is a specialized consulting firm that partners with pharmaceutical and biotechnology companies to quickly advance their drug development programs. With a team of 50+ associates experienced in guiding companies through the strategy and management of drug development, our core areas of expertise are:
Each PharmaDirections associate has more than 20 years of experience. Combined, they represent tenure at more than 40 of the world’s largest pharmaceutical companies. Whether working independently or as part of a unified team, PharmaDirections offers one of the most extensive networks of drug development professionals in the industry.