Industries · Consumer & Health

Life Sciences

Life sciences organisations work under validation and data-integrity rules that few other industries face, while guarding research, trial, and manufacturing data of enormous value. Fidova brings a security-first, connected approach to the systems behind research, trials, and production, so that compliance and protection are designed in rather than retrofitted. We help you build, secure, and govern across validated environments, laboratory and quality systems, and the data that supports every submission.

Build · Secure · Govern

One connected advisory, applied to the realities of life sciences.

What's at stake

The pressures shaping this sector.

Data integrity and validation

Regulated systems must demonstrate that data is attributable, complete, and unaltered. Validation and electronic-records requirements shape how every system is built, changed, and evidenced.

Intellectual property exposure

Research data, trial results, and formulations are prime targets for theft and espionage. A loss of this data can erase years of investment and competitive advantage.

Fragmented quality systems

Laboratory, manufacturing, and quality systems are frequently siloed across sites and vendors. The gaps between them slow submissions and make consistent control difficult to prove.

Extended supply and trial networks

Contract research, manufacturing, and clinical partners all handle regulated data. Their controls become part of your own compliance and security posture.

How Fidova helps

The disciplines that matter most here.

CybersecurityWe test research, laboratory, and manufacturing systems and design a security programme that protects intellectual property without disrupting validated operations.Governance, Risk & ComplianceWe build a rationalised control set with named owners and continuous evidence, aligned to GxP expectations, 21 CFR Part 11, and data protection law.SAPWe implement and secure SAP across manufacturing, quality, and supply, with GRC and controls suited to validated, regulated environments.Artificial IntelligenceWe help apply AI to discovery and trial analysis with data protection, documented human oversight, and governance that stands up to regulatory scrutiny.DevelopmentWe design and oversee delivery of research and quality systems with security and validation readiness engineered in from the start.

Regulation & frameworks

The obligations we design around.

We build controls, evidence and reporting to hold up against the frameworks this sector answers to — across the jurisdictions you operate in.

GxP (GMP, GLP, GCP)
FDA 21 CFR Part 11
EU GMP Annex 11
EU GDPR
India Digital Personal Data Protection Act 2023
ISO 27001
ICH guidelines (clinical and quality)

Get in touch

Tell us what you are deciding in life sciences.

Share the situation and we will come back with a considered view on scope, sequencing and where the real dependencies sit.

Prefer email? contact@fidovaadvisory.com