TECHNICAL & REGULATORY SERVICES

TECHNICAL &
REGULATORY SERVICES

Our team has an extensive “hands on” experience in delivering technical projects for our clients. All of our consultants have spent their working lives within the pharmaceutical, medical device and food supplement industry and have covered the product life-cycle from pre-clinical to post-marketing.

A few key services in our training arsenal are, but not limited to:

SERIALISATION (END TO END PROCESS)

REGULATORY SUPPORT

REMEDIATION ACTIVITIES

PROJECT MANAGEMENT

PACKAGING AND LABELLING

TECHNOLOGY TRANSFER

PACKAGING TRANSFER

LICENSING SUPPORT

EXCIPIENT RISK ASSESSMENTS

FORMULATION DEVELOPMENT

TEMPERATURE MAPPING

CONTAMINATION CONTROL

STABILITY MANAGEMENT

PHARMACOVIGILANCE

SUPPLY CHAIN MANAGEMENT

VALIDATION (PROCESS & EQUIPMENT CHANGE)

FACILITY DESIGN AND EQUIPMENT QUALIFICATION

PRODUCTION SYSTEM