TECHNICAL & REGULARITY SERVICES

  TECHNICAL &
  REGULARITY SERVICES

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

A few key functionalities that we provide our training services, but not limited to, are as below;

SERIALISATION (END TO END PROCESS).

REGULATORY SUPPORT.

REMEDIATION ACTIVITIES.

PROJECT MANAGEMENT.

SUPPLIER SOURCING.

TECHNOLOGY TRANSFER.

PACKAGING TRANSFER.

LICENSING SUPPORT.

EXCIPIENT RISK ASSESSMENTS.

FORMULATION DEVELOPMENT.

TEMPERATURE MAPPING.

CONTAMINATION CONTROL.

STABILITY MANAGEMENT.

PHARMACOVIGILENCE.

SUPPLY CHAIN MANAGEMENT.

VALIDATION (PROCESS & EQUIPMENT CHANGE).

FACILITY DESIGN AND EQUIPMENT QUALIFICATION.

PRODUCTION SYSTEM.

PACKAGING AND LABELING.