MHRA PLPI Licensing
End-to-end management of Parallel Import Product Licence applications — covering submissions, MHRA correspondence, variations, and post-approval pharmacovigilance obligations.
Two complementary entities operating at the intersection of pharmaceutical regulation and commercial market access — one anchored in the UK under MHRA oversight, one in India bridging global manufacturing to Western regulatory frameworks.
Company One
NovaPharm Healthcare Ltd is a UK-registered pharmaceutical company operating under MHRA regulatory oversight. The company specialises in Parallel Import Product Licence (PLPI) management, EU-GMP certified pharmaceutical sourcing, and GDP-compliant distribution to NHS Trusts, independent pharmacies, hospital procurement teams, and pharmaceutical wholesalers across the United Kingdom.
With deep expertise in the post-Brexit regulatory environment, the company provides a rigorous, transparent, and fully documented supply pathway for specialist and high-value pharmaceutical products — with a particular focus on oncology, hospital medicines, and high-cost therapies subject to NHS formulary and NICE HTA scrutiny.
What We Do
End-to-end management of Parallel Import Product Licence applications — covering submissions, MHRA correspondence, variations, and post-approval pharmacovigilance obligations.
Systematic audit and qualification of EU-GMP certified manufacturers, ensuring batch documentation integrity, supply chain traceability, and MHRA-standard supplier compliance.
Full-service parallel import logistics — sourcing, re-labelling, language compliance, customs documentation, and GDP-compliant UK distribution to licensed premises.
Strategic market access support for oncology and high-cost medicines — including NICE HTA engagement, NHS formulary submissions, and hospital procurement strategy.
Pharmaceutical distribution under GDP guidelines — temperature monitoring, cold chain management, qualified person oversight, and full audit trail documentation.
Expert guidance on MHRA-divergent regulatory pathways following Brexit — UK product registration, variation management, and dual UK/EU market strategy.
Company Two
Novapharm Innovation Technology (NovaPharm InfoTech) is the India-based pharmaceutical R&D and regulatory services subsidiary of the NovaPharm group. It operates out of Vadodara, Gujarat — a major hub for Indian pharmaceutical manufacturing — and provides a critical bridge between Indian pharmaceutical producers and Western regulatory requirements.
The company specialises in helping Indian manufacturers achieve and maintain compliance with MHRA (UK), EMA (EU), and Health Canada frameworks — enabling market access across three of the world's most demanding pharmaceutical jurisdictions. It also supports the NovaPharm Healthcare supply chain through regulatory due diligence, documentation, and supplier qualification services.
What We Do
Assisting Indian manufacturers with UK product registration, MHRA submission preparation, post-Brexit compliance documentation, and marketing authorisation applications.
European market entry strategy and EMA submission support — covering centralised procedures, national applications, and post-Brexit UK/EU regulatory divergence management.
Regulatory pathway assessment and submission support for pharmaceutical products seeking Canadian market authorisation — covering New Drug Submissions (NDS) and Abbreviated NDS.
Comprehensive regulatory due diligence for licensing deals, acquisitions, and partnership agreements — evaluating compliance status across MHRA, EMA, and Health Canada requirements.
Research and development support services for pharmaceutical formulations — including analytical method development, stability studies, and dossier preparation for international filings.
Supplier qualification, audit coordination, and documentation services linking Indian pharmaceutical manufacturing capability with NovaPharm Healthcare's UK-compliant supply chain.
Contact
For distribution partnerships, investment discussions, regulatory consulting enquiries, or media requests — reach out directly.