Where compliance meets confidence
Independent EU GMP/GDP audits, contract QP/RP/RPi cover and inspection-ready quality systems — led by a Qualified Person with 20+ years across regulated markets.
- Remote, on-site or hybrid
- UK · EU · US · MENA
- Audit-graded reporting
- 20+ yrs
- Pharma quality leadership
- QP · RP · RPi
- Qualified / Responsible Person
- GMP · GDP
- Lead auditor
- UK · EU · US · MENA
- Markets supported
- Audited & built against
- EudraLex Volume 4
- 21 CFR 210 / 211
- ICH Q7–Q10
- EU GDP 2013/C 343/01
- Annex 1
- ISO 13485
- GAMP 5
- 21 CFR Part 11
- WDA(H) · RPi
Quality & compliance, end to end
From a single supplier audit to ongoing QP/RP cover and full quality-system builds — delivered by one senior expert.
GMP & GDP Audits
Independent GMP/GDP, supplier and for-cause audits, mock regulatory inspections and inspection-readiness reviews.
Learn moreContract QP, RP & RPi
Qualified Person batch certification plus Responsible Person (WDA) and Responsible Person for import (RPi) cover.
Learn moreQMS & PQS Implementation
Build and remediate quality systems to ICH Q10 — SOPs, CAPA, deviations, change control and self-inspection.
Learn moreSite Readiness (MIA / WDA)
Prepare sites, dossiers and teams for MIA/WDA licensing, regulatory inspection and operational go-live.
Learn moreSupplier & Vendor Management
GxP supplier qualification, technical/quality agreements (QTA) and ongoing performance oversight.
Learn moreGDP Transport & Supply Chain
Transport validation, cold-chain assurance and distribution compliance across the GDP supply chain.
Learn moreWhatever stage of compliance you're at
Stay ahead of inspections, keep routine compliance on track, or recover quickly when something goes wrong.
Inspection Readiness
- Mock regulatory inspections
- GMP/GDP gap assessments
- Pre-approval inspection prep
- Self-inspection programmes
Routine Compliance
- Scheduled supplier audits
- Periodic self-inspections
- QMS / PQS health checks
- QP / RP oversight
Remediation & CAPA
- For-cause & triggered audits
- Post-inspection remediation
- CAPA design & effectiveness
- Data-integrity reviews
Balasubramanian
QP · RP · RPi · GMP/GDP Lead Auditor
Led by a hands-on Qualified Person, not a faceless firm
Double Helix Pharma is led by Balasubramanian, a Qualified Person (QP), Responsible Person (RP) and RP for import (RPi) with 20+ years in pharmaceutical quality across the UK, EU, US and MENA markets.
Having led quality & compliance teams, harmonised pharmaceutical quality systems, performed RP/RPi duties for the UK market and hosted regulatory GMP/GDP inspections, the practice brings an inspector's eye and an operator's pragmatism — from sterile and oncology injectables to biosimilars and solid oral dose.
- Qualified Person (QP)
- Responsible Person (RP)
- RP for import (RPi)
- GMP/GDP Lead Auditor
- PQS / QMS Expert
- 20+ years in pharma quality
A clear, inspection-grade method
Every engagement follows the same disciplined path — so you always know what happens next.
- 01
Scope & risk assessment
We agree objectives, the regulatory basis and risk priorities so effort lands where it matters most.
- 02
Plan & prepare
A clear agenda, document requests and logistics — delivered on-site, remote or hybrid to suit your site.
- 03
Execute
Rigorous, experienced assessment against the applicable GxP requirements — or hands-on implementation work.
- 04
Report
Clear, graded findings mapped to regulations and ranked by risk, so your team knows exactly what to fix first.
- 05
CAPA & follow-up
A practical corrective-action plan, effectiveness checks and re-assessment to close the loop and stay inspection-ready.
Experience across product types
Quality and compliance expertise spanning sterile and non-sterile manufacturing.
Sterile injectables
Sterile liquid & freeze-dried
Oncology injectables
High-potency handling
Biosimilars & biotech
Biological products
Solid oral dose
Tablets & capsules
APIs & raw materials
Active ingredients
Excipients
Supporting materials
Compliance isn't paperwork — it's patient safety. My job is to make sure you can walk into any inspection with complete confidence.
Frequently asked questions
What does a pharmaceutical quality & compliance consultant do?
We help pharma, biotech and CMOs meet GMP and GDP requirements — auditing sites and suppliers, acting as a contract QP/RP/RPi, building or remediating quality systems, and preparing teams for regulatory inspection.
Which markets and regulators do you cover?
Engagements span the UK (MHRA), European Union (EMA), United States (FDA) and the MENA region, drawing on 20+ years working to EU GMP/GDP standards.
Do you work with small, virtual or first-time pharma companies?
Yes. Whether you are a virtual company outsourcing to a CMO or preparing for your first MIA/WDA, engagements scale to your stage and budget.
Can you act as our contract QP, RP or RPi?
Yes — contract and interim QP (batch certification/release), RP (WDA) and RPi (import) cover is available. See the Contract QP, RP & RPi page for detail.
Ready to get inspection-ready?
Book a no-obligation discovery call to talk through your audit, QP/RP or quality-system needs.