Marketing Authorisation Applications
Preparation and review of regulatory applications and supporting documentation.
Explore service → PHARMACEUTICAL REGULATORY AFFAIRS
Regulatory Affairs Expertise for Human Medicinal Products
Specialist regulatory consulting services supporting pharmaceutical companies across the United Kingdom and European Union, from marketing authorisation applications and dossier assessment to post-authorisation lifecycle management.
✓UK & EU regulatory focus
✓Practical dossier expertise
REGULATORY PRECISION
15+
Years of professional
regulatory experience
United Kingdom &
European Union
End-to-end dossier &
lifecycle support
ABOUT NORD CONSULTING
Your Partner in Pharmaceutical Regulatory Affairs
NORD CONSULTING provides regulatory affairs consulting services for human medicinal products, supporting the preparation, assessment and maintenance of regulatory documentation in accordance with applicable UK and EU requirements.
We help pharmaceutical businesses identify regulatory requirements, address documentation deficiencies and manage activities throughout the medicinal product lifecycle.
Our expertiseOUR SERVICES
Comprehensive Regulatory Support
Specialist regulatory services designed to support medicinal products from initial authorisation through ongoing maintenance.
CTD/eCTD Dossier Preparation & Review
Dossier compilation, scientific documentation review, publishing and submission support.
Explore service →Regulatory Due Diligence
Structured dossier assessments, regulatory risk identification and compliance review.
Explore service →Variations & Lifecycle Management
Post-authorisation changes and ongoing regulatory maintenance.
Explore service →Regulatory Gap Analysis
Identification of regulatory deficiencies and development of remediation plans.
Explore service →SmPC, PIL & Labelling
Preparation, review and updating of medicinal product information.
Explore service →Regulatory Strategy & Scientific Support
Assessment of regulatory pathways and support for informed regulatory decisions.
Explore service →MA Transfers, Renewals & Regulatory Maintenance
Regulatory support for transfers, renewals and authorisation maintenance.
Explore service →WHO WE SUPPORT
Regulatory Support Tailored to Pharmaceutical Businesses
We work with organisations involved in the development, authorisation, commercialisation and management of human medicinal products.
01Marketing Authorisation Holders (MAHs)
02Pharmaceutical manufacturers and developers
03Generic and innovative pharmaceutical companies
04Pharmaceutical portfolio owners and investors
05Organisations outsourcing regulatory expertise
OUR APPROACH
A Structured Approach to Regulatory Challenges
01
Assessment
Understand product documentation and regulatory objectives.
02
Planning
Define regulatory activities, priorities and deliverables.
03
Documentation
Prepare, review and improve regulatory documentation.
04
Regulatory Support
Support implementation, submission activities and follow-up.
15+
YEARS OF PROFESSIONAL EXPERIENCE
WHY NORD CONSULTING
Focused Expertise. Clear Documentation. Practical Support.
We recognise that regulatory projects require technical accuracy, effective communication and attention to applicable requirements.
Our flexible, structured consulting approach is tailored to the priorities of each project, with extensive European regulatory experience complemented by additional international exposure.
GET IN TOUCH
Let's Discuss Your Regulatory Project
Whether you require assistance with a marketing authorisation, dossier review, due diligence or post-authorisation activities, contact NORD CONSULTING.