Why ECTD Pharma is the UK’s Secret Weapon for Indian Pharma Companies

Tom Marsden
Aug 12
3 min read

How Specialized Regulatory Expertise Accelerates US, EU, and UK Approvals

The Challenge: Technical Hurdles in Global Submissions

Indian pharmaceutical companies are vital to global healthcare, producing 60% of the world’s vaccines and 20% of generic medicines. However, many face persistent delays in securing approvals from the US FDA, EU EMA, and UK MHRA—not due to weak science, but because of technical eCTD submission errors.

The Cost of Submission Failures

FDA rejections can delay approvals by 4-6 months, costing over $500,000 in lost revenue per product.
EMA validation errors force costly resubmissions, straining timelines.
Post-Brexit MHRA requirements introduce new complexities that catch firms off guard.

Why Do These Issues Persist?

Many Indian pharma companies rely on:

Overburdened in-house teams lacking specialized FDA/EMA publishing expertise.
Global CROs that treat them as secondary clients, leading to slow turnaround times.
Local consultants who excel in strategy but lack executional precision in eCTD formatting.

The Solution: A UK-Based Regulatory Publishing Partner

ECTD Pharma is a UK-focused regulatory publishing specialist with 30+ years of experience, offering Indian firms a faster, more reliable path to approvals.

Key Advantages Over Traditional CROs

Global CROs	ECTD Pharma
4-6 week turnaround	10-day guaranteed delivery
Generic templates	Tailored submissions
High error rates	Zero rejections—or we fix for free
Expensive markups	Lower costs
Offshore teams	UK-based experts with 30 Years experience within big pharma

How We Ensure First-Time Approval Success

1. Guaranteed Acceptance

We provide a contractual guarantee that submissions will pass technical validation.

AI-powered pre-validation identifies errors before submission.
Expertise in Freyr SUBMIT PRO ensures flawless XML, bookmarks, and hyperlinks.
If a regulatory agency rejects the submission for formatting, we correct it at no additional cost.

Case Study:An Indian generics manufacturer faced three consecutive FDA rejections for an ANDA due to Module 3 granularity issues. After engaging ECTD Pharma, we restructured the submission in five days, securing acceptance on the next attempt.

2. Faster Turnaround Times

72-hour emergency submissions for critical deadlines.
Dedicated UK team eliminates time-zone delays.
Real-time SharePoint tracking provides full visibility.

Example:A Hyderabad-based biosimilar company needed an EMA submission completed in two weeks to meet a funding milestone. Their CRO deemed it impossible. We delivered in nine days.

3. MHRA Post-Brexit Specialization

Since Brexit, UK submissions require precise local expertise.

MHRA-ready formatting prevents last-minute surprises.
Dual EU/UK submissions streamlined for efficiency.

4. White-Label Publishing for Indian CROs

Many Indian consultancies lack in-house publishing teams.

We act as your silent UK publishing partner.
Your branding, our execution.

The Business Impact for Indian Pharma

1. Faster Approvals, Faster Revenue

Every month saved in approval timelines can mean $100,000+ in early revenue for generics.
First-to-market biosimilars gain pricing advantages.

2. Lower Costs Than Global CROs

High Cost reduction due to lean operations
No hidden markups.

3. Eliminate Rejection Risks

Investors and partners lose confidence with repeated delays.
Our guarantee ensures no avoidable setbacks.

Who Should Consider This Solution?

Indian Generics Manufacturers – ANDAs, 505(b)(2)s, DMFs.
Biosimilar/Biologics Firms – Complex Module 3 expertise.
Indian CROs & Consultants – Expand capacity without overhead.
Virtual Biotechs – Plug-and-play regulatory support.

Next Steps

Free Submission Audit – Send your last rejected dossier for a no-cost error analysis.
Pilot Project Offer – Test our services with 20% off your first submission.
White-Label Partnerships – Scale your publishing capabilities seamlessly.