TRIPHASE provides drug product development consulting services in
the area of quality assurance (QA) and quality control
(QC). Today’s demanding regulatory
environment requires solutions that maintain high quality,
without draining valuable resources. Our expert
consultants can support or supplement your internal
quality resources and deliver solutions that accelerate
your product development.
Quality Assurance Support
Our quality experts can assist your quality assurance
staff by preparing or reviewing SOPs, documents and
approving study reports, specifications, analytical
methods, or process qualifications.
Quality Systems Evaluation and
TRIPHASE has extensive experience in conducting Q7A
(API), 21 CFR 210-211 (Drug Product), and ICH
Guidances quality audits of raw material suppliers, contract
manufacturers, and contract research organizations.
Using our proprietary Audit Check List, we quickly and
efficiently cover all aspects of GMP compliance at an
We provide advanced training on such topics as quality
and regulatory requirements throughout development,
GMP compliance, and pre-approval inspection readiness.
Quality System Design
Our experts will design a quality system that meets
both regulatory expectations and the development stage
of a company’s products. A complete quality system
will include the documents and procedures necessary to
establish a quality unit at your company and define
corporate quality policies