Product Development & Design

and getting them from , through development, to manufacturing as efficiently and effectively as possible is a complex task. Deep knowledge of how new products and medicines are developed, the processes, science and technologies used, really helps to understand, support and contribute to your inforamtics projects in this domain.

Handover of analytical testing processes, manufacturing process parameters, product specification data transfer, data integrity support, validation & compliance, manufacturing plant design

Study design (DoE) and planning, sample tracking and pull date scheduling, environmental monitoring, sample testing and analytical test results capture, study results aggregation, validation, statistical analysis

New quality system design/delivery/maintenance, auditing against regional regulatory guidelines (21CFRpart11, GLP, GMP, GCP, GAMP5), quality system audit and recommendations, quality system best practice adoption

Instrument validation strategy, IQ, OQ, PQ qualification, risk-based approaches, execution and reporting across 21 CFR part 11, GLP, GMP, GAMP for all analytical instrument hardware platforms

Early Pharmacology, ADME, Assay Automation, PK/PD, Assay Development & Validation, Bioanalysis, Inventory Management etc. and the linked regulatory aspects of GLP and IND/NDA/BLA creation support.

data integrity company - zifo - scientific informatic company

CDM meeting 21CFR Part 11, EUANNEX Part 11 and GDPR, experience with numerous data analysis/review tools and processes suggested by GCDMP

CMC - product development company

Aggregating and ensuring the regulatory integrity of information for specifications, manufacturing process control parameters, stability parameters and analytical test variance data.

"Always on", end-user support, proven scale, quality, processes and knowledge of scientific applications have a measurable impact on end-user efficiency, satisfaction and application downtime.

Automated assay and screening, batch release, workflow orchestration, BPMN, low-code-no-code process automation (RPA) and robotics platforms.

Process optimisation, automation, validation and QC through BPMN, technology and change management to automate business rules to support decisions and scale

Assay development and validation, instrument data acquisition and integration, regulatory and QC data reporting, lab inventory and metrology, workflow automation and validation