Building Market Ready Pharma Products Beyond Launch with CMO Pharma Expertise
From early development to global commercialisation, we help pharma teams simplify manufacturing challenges through CMO pharma expertise and meet worldwide regulatory requirements.
The Core Philosophy The Product Lifecycle
Most GTM failures happen due to fragmented planning. We bridge the gap between clinical development and commercial supply.
Our Services
Featured Service CMO Support & Production Scaling
Partner Selection
We identify and audit CMOs based on your specific dosage form and volume requirements, ensuring a perfect technical fit.
Quality Oversight
We manage tech transfer processes to meet FDA, EMA, eliminating the regulatory bottlenecks that cause launch delays.
Supply Chain De risking
We build redundancy into your manufacturing footprint, protecting your brand from stock outs and market volatility.
Why Partner With Us?
Global Compliance: Deep expertise in international regulatory landscapes.
Technical Liaison Model: We speak the language of both the boardroom and the manufacturing floor.
Risk Mitigation: We identify “single points of failure” in your supply chain before they become crises.
Our Thought Leadership
We are a multidisciplinary team of industry professionals who have worked inside pharma, biotech, and healthcare organisations. This real-world experience allows us to deliver practical, execution-ready strategies not just recommendations.
Caleb Benjamin Masih
Executive Director
A pharmaceutical industry leader with 25+ years of experience across general management, sales, marketing, and operations. He has led global and Indian organisations, driving product launches, P&L performance, and scalable growth across the full product lifecycle.
FAQs
At what stage should we engage your consultancy?
Ideally, 18–24 months before your projected launch. Early intervention in CMO selection prevents costly tech-transfer pivots later.
How do you ensure our IP is protected during CMO audits?
We operate under strict NDAs and implement rigorous data-room protocols during the partner selection and auditing phases.
Can you help if we already have a CMO but are experiencing quality delays?
Yes. We provide “rescue consultancy” to audit existing tech transfer processes and implement corrective actions (CAPA) to get your timeline back on track.
Does your consultancy assist with orphan drugs or specialised therapies?
Specialised therapies often face the steepest hurdles regarding pricing and reimbursement. Our framework is designed to handle the nuanced data requirements and unique HTA pathways required for niche medical breakthroughs and rare disease treatments.
What specific stress tests occur during Regulatory Sandboxing?
We simulate a range of high-pressure scenarios, including unexpected requests for additional data, shifts in the competitive landscape during the filing period, and potential labeling restrictions. By identifying these hurdles in a controlled sandbox, we allow your team to refine the submission strategy before official filing.
Can your Pricing & Reimbursement models adapt to different global HTA requirements?
Yes. We design multi-layered models specifically customised to satisfy various Health Technology Assessment (HTA) bodies. Whether you are navigating the complexities of the ICER in the US or various European authorities, we ensure your pricing reflects the product’s value while maintaining long-term profitability.
Ready to Secure Your Product’s Future?
Don’t let manufacturing hurdles stall your innovation. From the first CMO audit to global scaling, let’s build a resilient GTM strategy together.