Helix — Pharma & Life Sciences (Enterprise · 3D)
GMP-certified life sciences

Science that moves from molecule to market

An end-to-end pharma partner — discovery, clinical supply, GMP manufacturing and regulatory affairs, under one accountable roof.

GMPCertified
300+Molecules
40+Approvals
98%
Batch success
300+
Molecules advanced
40+
Regulatory approvals
21 CFR
Part 11 compliant
The challenge

Drug development is slow, costly and unforgiving

Handoffs between vendors lose time, data integrity and — ultimately — patients' chances.

Fragmented vendors

Discovery, trials and manufacturing rarely speak the same language.

Compliance risk

One data-integrity gap can derail an entire submission.

Lost time

Every delayed batch pushes back a life-changing therapy.

The solution

One integrated life-sciences partner

From assay to approval — a single, data-integral chain of custody with science you can audit at any moment.

  • Discovery & lead optimisation
  • Clinical trial material & supply
  • GMP manufacturing & regulatory dossiers
How it works

A clear path to the clinic

1

Discovery

Screening, assays and lead optimisation.

2

Develop

Process & formulation, scale-up to GMP.

3

Deliver

Clinical supply, dossiers and submission.

Capabilities

Built for regulated science

Discovery science

Medicinal chemistry, biology and DMPK.

GMP manufacturing

Sterile & non-sterile, small to commercial scale.

Regulatory affairs

IND/IMPD, NDA/MAA, global submissions.

Data integrity

21 CFR Part 11, ALCOA+ across every system.

Cold chain

Validated 2–8°C and cryogenic logistics.

Pharmacovigilance

Safety monitoring and reporting built in.

Inside the lab

A facility engineered for purity

NovexaCytivaHeliosBiomarkAterna
Client stories

Trusted by leading biotechs

★★★★★

"Helix took our compound from lead optimisation to IND-ready in record time, with flawless documentation."

Dr. A. Rao · Head of R&D, Novexa Bio
★★★★★

"Their GMP facility and regulatory team made our FDA submission genuinely painless."

Dr. M. Klein · VP Regulatory, Cytiva Labs
★★★★★

"Quality, transparency and science you can trust. A real life-sciences partner."

Dr. P. Shah · CSO, Helios Therapeutics
Why Helix

The integrated advantage

Capability
Helix
Point vendors
Single chain of custody
In-house regulatory team
21 CFR Part 11 systems
Discovery → commercial scale
Engagement models

Partner at any stage

Discovery

Project

For early-stage research.

  • Assay development
  • Lead optimisation
  • DMPK studies
Discuss a project
Most chosen

Development

Program

For IND-enabling work.

  • Process & formulation
  • GMP scale-up
  • Clinical supply
  • Regulatory dossier
Talk to our scientists

Commercial

Custom

For approved products.

  • Commercial GMP supply
  • Lifecycle management
  • Global PV & QA
Contact us
FAQ

Questions, answered

Are you GMP and FDA compliant?+

Yes — our facilities are GMP-certified and operate to FDA, EMA and ICH standards with full 21 CFR Part 11 systems.

Can you support our regulatory submission?+

Our in-house regulatory team handles IND/IMPD through NDA/MAA across major markets.

How do you protect our IP?+

Strict segregation, audited access controls and watertight confidentiality agreements.

What scales can you manufacture at?+

From gram-scale clinical batches to commercial-scale production.

Let's advance your molecule

Book a confidential consultation with our scientific team.

Book a confidential consultation with our scientistsBook now
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