MAI Consulting Professionals

 

Example Projects

Quality Systems

Capabilities range from developing corporate quality standards to FDA audit remediation and SOP development in manufacturing, pre-clinical, clinical and pharmacovigilance environments. GMP, GCP, GLP, ICH, ISO, EMEA, OECD.

Project Management

Capabilities range from software development, implementation and Part 11 compliance to GxP/BSL facilities construction, compliance, and training.

Computer System Validation

Capabilities range from enterprise-wide inventory and assessment to IQ/OQ/PQ development and execution.

Electronic Batch Records

Capabilities range from evaluation and implementation of commercial systems to design and development of proprietary systems.

Business Process Re-engineering

Capabilities range from redesign of technology transfer process to evaluation of continuous improvement programs, quality system redesign, and master batch record redevelopment.

ANDA Development

MAI has assembled a team of experienced consultants to bring your generic products to market. In addition to preparating the ANDA submission, our approach includes a market assessment and risk assessment to ensure that your target product will (1) get the return you expect, and (2) will be approved. Once the ANDA is submitted, we will help you prepare for your PAI (pre-approval inspection) and identify the right distribution channel.

MANDATE EBR Development Project

We are currently recruiting companies to partner with us as we develop an internet-based EBR system that will be offered either as a service ("software as a service") or for purchase. We offer very favorable terms for your company's participation.