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.