CMC Management • QP Services • Clinical Packaging • Regulatory Submissions
Chemistry Manufacturing Control (CMC) Management:
AlthoTech’s expertise is in the CMC aspects of new product development, taking responsibility for subcontracting and executing all GMP activities for its clients following the declaration of a product candidate (progressing new drugs from the laboratory into clinical trials), including:
AlthoTech negotiates contracts and timelines and ensures delivery on time and within budget. AlthoTech has extensive experience in negotiating contracts and has delivered very competitive pricing for its clients.
AlthoTech has an impressive track record in rapid development to IND without compromising quality - average under 12 months from declaration of a product candidate to filing.
AlthoTech has qualified clinical packaging preferred vendors in both North America and Europe for the primary and secondary packaging of clinical supplies.
Clinical packaging capabilities include:
AlthoTech has considerable experience in the filling and labelling of complex blinded studies and the design of trial specific patient packs.
AlthoTech specializes in regulatory filings for early stage clinical trials and has proven success in: