Strategic planning for new product development 30 years in global product development for pharmaceutical companies. Meet ICH Guidance E6 Good Clinical Practice Guidance for the sponsor to ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s).
This includes identification of appropriate CRO, bid defense, document review, sponsor audits, report reviews, etc. Good for companies with no clinical departments or limited bandwidth or ex-US companies performing trials in the US. Includes clinical endpoint studies and bio-equivalence studies.
This includes identification of appropriate CRO, bid defense, document review, sponsor audits, report reviews, etc. Good for companies with no clinical departments or limited bandwidth or ex-US companies performing trials in the US. Includes clinical endpoint studies and bio-equivalence studies.
Services
Reg-Tec, Inc. is an experienced Regulatory Affairs and Clinical Project Management Consulting Company focusing on small to medium-sized, branded and generic pharmaceutical companies. By providing comprehensive drug development services for the ANDA and 505(b)(2) and NDA approval pathways, Reg-Tec, Inc. systematically builds and executes complete development plans that align with business strategies and ensure FDA efficiency every step of the way.
Reviews
Be the first to review Regent Technologies.
Write a Review
