Health Canada — New Drug Submissions (NDS)
Full NDS preparation and submission management including safety, efficacy, and quality modules — aligned with the Common Technical Document (CTD) format and Health Canada review standards.
Markets
Global Pharmaceutical Regulatory Intelligence Across Seven Markets
Our leadership team brings 70+ years of combined pharmaceutical expertise across the world's most complex and high-value regulatory environments — enabling coordinated, efficient global market entry for pharmaceutical partners.
CA / US
North America
Deep market intelligence in the techno-commercial domain with regulatory expertise spanning both the Canadian (Health Canada) and United States (FDA) pharmaceutical regulatory frameworks. Our leadership team understands both the scientific and commercial dimensions of North American market entry.
Health Canada — ANDS & Generic Strategy
Abbreviated New Drug Submission (ANDS) strategy and preparation — comparative bioavailability studies, bioequivalence assessment, and regulatory pathway planning for generic pharmaceutical entry.
Supplemental Submissions & Lifecycle
Supplemental NDS and ANDS management — label changes, new indications, manufacturing site variations, and post-market safety reporting to Health Canada throughout the product lifecycle.
Regulatory Pathway Strategy
Strategic regulatory roadmapping for the North American market — identifying the most efficient approval pathway, pre-submission meeting preparation, and coordinated Canada/US submission strategy.
Techno-Commercial Market Intelligence
In-depth market analysis integrating regulatory, patent, and commercial data — including competitive landscape assessments, market sizing, and opportunity identification across Canada and the USA.
Cross-Border Coordination (CA + US)
Coordinated regulatory strategy spanning both Health Canada and FDA frameworks — enabling efficient parallel submission programmes and harmonised development programmes for North American market entry.
United Kingdom
United Kingdom
Post-Brexit regulatory navigation and MHRA compliance excellence — with a unique competitive advantage through our sister company, NovaPharm Healthcare Ltd, which provides in-house pharmaceutical distribution capability across the UK.
MHRA Marketing Authorisation Applications
Preparation and submission of Marketing Authorisation Applications (MAA) to the MHRA — including new active substances, generic applications, and hybrid applications under post-Brexit UK regulatory frameworks.
Parallel Import Licensing (PLPI)
End-to-end MHRA Parallel Import licensing management — application preparation, Patient Information Leaflet (PIL) localisation, packaging compliance review, and ongoing MHRA correspondence.
Post-Brexit Regulatory Navigation
Expert guidance on the divergence between UK and EU regulatory frameworks post-Brexit — including Northern Ireland Protocol considerations, UKCA vs CE marking, and MHRA-specific submission requirements.
Variation Management & Lifecycle
Post-authorisation variation submissions to MHRA — Type IA, IB, and II variations, label updates, manufacturing site changes, and safety variation management throughout the product lifecycle.
In-House UK Distribution
A unique advantage — direct access to pharmaceutical distribution in the UK through our parent company NovaPharm Healthcare Ltd, providing a seamless pathway from regulatory approval to market supply for qualifying products.
GDP Compliance & Distribution Strategy
Good Distribution Practice compliance advisory, wholesale distribution licence (WDA(H)) guidance, and distribution channel strategy for pharmaceutical products entering the UK market post-approval.
European Union
European Union
Comprehensive understanding of EMA regulatory frameworks, product development strategy, and hybrid application pathways — enabling coordinated, efficient EU-wide market authorisation for pharmaceutical partners.
EMA Centralised Procedure (CP)
Centralised procedure applications for innovative and biotechnology products — including pre-submission scientific advice, dossier preparation, and EMA Committee for Medicinal Products for Human Use (CHMP) correspondence management.
Decentralised Procedure (DCP) & MRP
Decentralised Procedure and Mutual Recognition Procedure strategy and management for multi-country EU market access — including Reference Member State selection, dossier alignment, and national authority coordination.
Hybrid Application Strategy
Hybrid applications combining new and established reference data — a strategically important pathway that Novapharm Innovation Technology has specific expertise in structuring and executing efficiently.
Product Development Strategy
EU regulatory strategy from early development — target product profile definition, regulatory pathway selection, scientific advice preparation, and CTD-format dossier development aligned with EMA guidelines.
EMA Post-Authorisation Requirements
Post-authorisation safety studies (PASS), post-authorisation efficacy studies (PAES), variations, Periodic Safety Update Reports (PSURs), and Risk Management Plan (RMP) maintenance.
EU–UK Regulatory Divergence Strategy
Expert coordination between EMA and MHRA submission programmes — managing regulatory divergence post-Brexit to minimise duplication and maximise efficiency across simultaneous EU and UK market entry programmes.
Emerging Markets
Expanding Global Presence
Beyond our three core markets, Novapharm Innovation Technology is building capability and partner networks across four additional high-growth pharmaceutical markets.
Emerging pharmaceutical market with growing regulatory infrastructure. We support market intelligence, product registration advisory, and business development partnerships across the MENA region.
India serves as Novapharm Innovation Technology's R&D and operations hub — combining access to world-class pharmaceutical manufacturing infrastructure with a highly skilled scientific talent base.
The TGA-regulated Australian pharmaceutical market represents a strategic opportunity for partners with established MHRA or EMA approvals. We provide regulatory intelligence and market entry advisory for Australia.
Our network and regulatory intelligence capabilities extend to additional markets on a project basis. Contact us to discuss your specific market entry requirements.