Pharmaceutical Regulatory Consulting
Built for Approval.
Not Just Paperwork.
Getting a drug approved isn't a single filing; it's a strategy that has to hold up across preclinical data, clinical evidence, manufacturing information, and post-approval commitments. We guide sponsors through NDA, ANDA, BLA, and MAA submissions with a strategy built for approval.
5Health Authorities
Overview
End-to-End Regulatory Strategy
We work with sponsors from early development through post-approval, building a regulatory roadmap that anticipates agency questions before they're asked.
Our consultants have hands-on experience navigating the review processes of the FDA, EMA, MHRA, Health Canada, and TGA, helping sponsors avoid delays caused by incomplete or misaligned submissions.
- Regulatory pathway and classification assessment
- Gap analysis of your existing data package
- CTD/eCTD compilation aligned to ICH format
- Post-submission query and RTQ management
What We Deliver
NDA, ANDA, BLA & MAA Expertise
Submission strategy and preparation across every major drug approval pathway.
NDA Submissions (FDA)
Strategy, documentation, and agency interaction for New Drug Applications.
ANDA Filings
Generic drug submission support and bioequivalence strategy.
BLA Submissions
Biologics License Application planning and preparation.
MAA Consulting (EMA)
Marketing Authorization Application strategy for the European Union.
CTD / eCTD Compilation
Common Technical Document assembly aligned to ICH format.
5Major Health Authorities
5Global Regions
ISO9001:2015 Certified
10+Years of Expertise
Our Approach
From Pathway to Approval
A five-step framework that de-risks every module before it reaches the agency.
01
Assess
Regulatory pathway and classification assessment for your product.
02
Analyse
Gap analysis of the existing data package against agency expectations.
03
Plan
Submission strategy and realistic timeline planning.
04
Prepare
Document preparation and agency liaison support.
05
Respond
Post-submission query and deficiency response management.
Why Vigilare
A Strategy Built for Approval
Four reasons sponsors trust Vigilare with their global submissions.
Direct Five-Agency Experience
Hands-on experience with FDA, EMA, MHRA, Health Canada and TGA review processes.
Approval, Not Just Filing
Roadmaps built backwards from the questions agencies actually ask.
Integrated Writing & Publishing
Regulatory writing and eCTD publishing under one roof — no version drift.
Named Senior Leads
The same accountable regulatory lead from strategy through approval.
FAQs
Answered. Clearly.
01
How do I submit an NDA or an ANDA?
Submitting an NDA or ANDA involves compiling a complete data package — including clinical, nonclinical, and manufacturing information — into the CTD/eCTD format and filing it with the relevant health authority, such as the FDA.
02
What is regulatory consulting in pharma?
Regulatory consulting helps pharmaceutical companies plan submission strategy, prepare required documentation, and manage communication with health authorities to achieve product approval.
03
How do I get drug approval globally?
Global drug approval requires tailoring submissions to each region's specific requirements, such as NDA/ANDA for the FDA or MAA for the EMA, while maintaining consistent core clinical and safety data.
Related Services
Explore the Full Practice
Ready to plan your submission strategy?
Talk to a senior regulatory expert about your NDA, ANDA, BLA or MAA pathway — not a sales rep.