A specialist quality & compliance practice you can trust
Double Helix Pharma UK Ltd pairs the rigour of a large consultancy with the directness of working one-to-one with a senior Qualified Person.
Balasubramanian
Principal Consultant
- Qualified Person (QP)
- Responsible Person (RP)
- RP for import (RPi)
- GMP/GDP Lead Auditor
- PQS / QMS Expert
- 20+ years in pharma quality
An inspector's eye, an operator's pragmatism
Double Helix Pharma is led by Balasubramanian, a Qualified Person (QP), Responsible Person (RP) and RP for import (RPi) with over 20 years in pharmaceutical quality for highly regulated US, UK, EU and MENA markets.
Across that career the focus has been constant: implement a high standard of quality, keep sites inspection-ready, and protect patient safety while helping the business move forward — from sterile and oncology injectables and biosimilars to solid oral dose, APIs and excipients.
Functional expertise
- GMP/GDP compliance audits
- Site readiness for GMP/GDP/MIA/WDA operating models
- Contract QP / RP / RPi activities
- PQS/QMS implementation to ICH, FDA & EMA requirements
- QC testing lab relocation & requalification
- QA SOPs, protocols, reports & batch release
Technical skills
- Pharmaceutical Quality Systems (PQS) expert
- GMP/GDP expert — QP, RP & RPi
- GMP/GDP Lead Auditor
- GxP supplier management
- GDP transport validation & supply-chain management
- QA & QC leadership; global project management
20+ years, distilled
A selection of the experience behind every engagement.
- 20+ years in pharmaceutical quality across US, UK, EU and MENA markets.
- Led quality & compliance teams and harmonised pharmaceutical quality systems across group sites and affiliates.
- Performed Responsible Person (RP) and RPi duties for the UK market.
- Managed and hosted regulatory GMP/GDP inspections and chaired quality risk-management board meetings.
- Supported EU/UK batch release and improved third-party CMO relationships.
- Authored and reviewed SMF, VMP, VPP, QTA, change control, deviation, OOS/OOT/OOC, CAPA and Product Quality Reviews.
- Oversaw equipment and utility qualification — URS, DQ, IQ, OQ and PQ.
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.
Let's talk about your quality goals
Whether it's a single audit or an ongoing partnership, you'll always work directly with a senior expert.