Rapid development cycle
Each project is unique. CIMA has a track record that demonstrates accelerated
development cycles. CIMA efficiently manages and executes projects from feasibility
prototyping to successful regulatory review and commercial launch.
R&D and packaging development
CIMA formulation scientists, drug-delivery research experts and packaging engineers
work together to research new technologies, develop products, produce pilot scale
batches for clinical trials, and scale and transfer new products for commercial
manufacture.
Regulatory affairs experience
In-house regulatory professionals advise and guide you through regulatory filings.
This expertise is built on 16 major FDA and ex-US submissions since 2003.
Analytical development and stability
Experienced analytical scientists provide a full range of analytical test method
development, validation and sample analysis for all stages of drug development.
A team dedicated specifically to product stability manages programs from regulatory
submission through commercial production. Labs operate in strict compliance with
regulatory standards and provide timely data reporting.
Quality assurance and control
From receipt of raw material to finished product release, CIMA manufactures products
in FDA-inspected facilities that operate under current Good Manufacturing Practices
(cGMP). Our inspection history includes numerous pre-approval and GMP inspections
by FDA, MHRA-UK, EMEA and ANVISA-Brazil. CIMA facilities are DEA-approved to handle
controlled substances.
Project management
The CIMA project manager and dedicated development team work with you from feasibility
through commercial launch.
Manufacturing
CIMA’s U.S. and European facilities can meet your needs, from clinical supplies
through commercial manufacturing.
Alliance management
A dedicated alliance manager works with you to ensure the success of your ongoing
program.
Phase I and Phase II clinical trial management
From manufacturing clinical supplies to regulatory submissions, and from setup with
CROs to execution, CIMA can manage every aspect of your Phase I/II clinical studies.