Biopharma consulting from people who have run the lines.

Arinova helps manufacturers, investors and health authorities build compliant, efficient sterile operations: from GMP and quality systems to CMO management, technology transfer and the next generation of pharmaceutical innovation.

Email [email protected]See our expertise

Based in Dubai, UAE. Working across Europe, the Middle East and Asia.

70+ years combinedin quality, site leadership and global pharma management
EU GMP Annex 1 (2022)and FDA 21 CFR 210/211 sterile manufacturing
QP-eligible leadershipunder EU Directive 2001/83/EC
Three continentsof leadership experience across Europe, South America and Asia

What we do

We work where quality, operations and business decisions meet. Each engagement is led by senior practitioners, not handed down to junior teams.

Quality and GMP management

Quality systems that hold up in front of any inspector, and teams that can run them.

QMS design, gap assessment and remediation
FDA 483 and Warning Letter response
EMA, FDA and national authority inspection readiness
QP support and batch certification readiness
Deviation, CAPA and change control systems
Data integrity and quality culture programs

Sterile manufacturing and operational excellence

Aseptic operations that are compliant, efficient and robust at the same time.

Annex 1 (2022) implementation and Contamination Control Strategy
Aseptic filling line design, oversight and optimisation
Isolator and RABS bio-decontamination validation
Aseptic process simulation and intervention assessment
Qualification and validation of equipment, processes and cleaning
Engineering support, P&IDs and facility design review

CMO and CDMO management

Choosing, onboarding and overseeing manufacturing partners on your behalf.

CMO/CDMO scouting, qualification and audits
Quality agreements and technical agreements
Person-in-plant and QA oversight
Performance governance, KPIs and escalation
Technology transfer between sites and regions
Supply continuity and second-source strategies

Plasma, biologics and specialty products

Deep experience in plasma-derived medicines and complex biologics.

Plasma collection and SoHO compliance
Plasma fractionation strategy and contract fractionation
Insulin and GLP-1 pen assembly and fill-finish
Oncology manufacturing and quality support
Medical affairs and clinical trial support
Market entry and regulatory pathways in MENA

Innovation and new technologies

Bringing novel platforms from the lab to a regulated, manufacturable product.

Organ-on-Chip (OOC) diagnostic innovation
GMP-readiness for novel therapies and devices
Business cases and investor-ready roadmaps

Featured programs

Beyond advisory mandates, we shape long-term initiatives that strengthen regional pharmaceutical capability.

Local manufacturing

Insulin and GLP-1 manufacturing for the GCC

The MENA region has the highest diabetes prevalence in the world, yet most insulin and GLP-1 therapies are imported. We have designed a phased, low-risk roadmap to build local supply capability in the UAE, starting at the end of the value chain and moving upstream as the organisation matures.

Phase 1

Oral antidiabetics

Establish a GMP organisation and local manufacturing licence with solid-dose products.

Phase 2

Pen assembly

Add insulin and GLP-1 pen assembly under GMP, building sterile handling capability.

Phase 3

Aseptic fill and finish

Extend into sterile cartridge filling for insulin analogues and GLP-1 agonists.

Innovation

Organ-on-Chip technologies

Organ-on-Chip systems reproduce human tissue function on microfluidic devices, opening new routes to diagnostics and to faster, more human-relevant drug development. We advise innovators on taking these platforms toward regulated, scalable products.

Development strategy for Organ-on-Chip (OOC) diagnostic platforms
Quality and regulatory readiness for device, diagnostic and pharmaceutical pathways
Manufacturing scale-up and partner selection
Investor and partner communication grounded in technical reality

Plasma

Plasma collection and fractionation readiness

We help blood establishments and investors raise plasma collection to EU GMP standard, prepare for authority inspections, and secure contract fractionation, so that plasma collected locally returns as immunoglobulins, albumin and coagulation factors for local patients.

Feasibility and financial modelling for collection and fractionation programs
GMP and SoHO upgrade of transfusion and collection centres
Fractionator partnering, plasma master file and inspection support

How we manage your CMOs

Outsourced manufacturing only works when someone owns the relationship with technical depth. We act as that owner, from first audit to routine supply.

Assess

Define product, capacity and regulatory needs, then screen and audit candidate CMOs and CDMOs.

Contract

Negotiate quality and technical agreements that make responsibilities clear and enforceable.

Transfer

Lead technology transfer, qualification and process validation through to first commercial batches.

Oversee

Provide ongoing QA oversight, KPI reviews and person-in-plant support to keep supply on track.

Our experts

Arinova brings together former quality heads, site directors and business leaders from top global pharmaceutical companies.

70+

years of combined experience at every level of pharmaceutical manufacturing, from the cleanroom floor and QA release to site leadership and international business management.

Quality leadership

QP-eligible leadership under EU Directive 2001/83/EC
Heads of QA and GMP technology transfer
FDA Warning Letter and 483 remediation
EMA, FDA and national authority inspections

Site and operations leadership

Site directors of sterile and biologics plants
Aseptic filling and plasma fractionation operations
Technology transfer across Europe and the Middle East
Facility start-ups, engineering and validation

Global business leadership

Business leaders of top global pharmaceutical companies
Regional management across Europe, South America and Asia
Market access and local manufacturing strategy
Investor and partner programs in MENA

Let's talk about your project

Tell us briefly what you are planning, whether it is an inspection, a new facility, a CMO partnership or a new technology. We reply within two business days.

Write to us

Company: Arinova Biopharma Consulting L.L.C-FZ
Location: Dubai, United Arab Emirates
Registration: IFZA, Dubai
Email: [email protected]