Services
An integrated portfolio of pharmaceutical services spanning the complete regulatory, scientific, and commercial lifecycle — from early-stage formulation and IP strategy through to regulatory submission, project management, and global market launch.
Compliance and submission expertise across the UK, EU, and North American regulatory frameworks — helping pharmaceutical companies navigate complex approval pathways efficiently and confidently.
Marketing Authorisation applications, Parallel Import licensing (PLPI), Variation management, and ongoing MHRA correspondence and reporting — with in-house UK distribution capability through NovaPharm Healthcare Ltd.
Centralised procedure (CP) applications, Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), and hybrid application strategy for EU-wide market authorisation.
New Drug Submissions (NDS), Abbreviated New Drug Submissions (ANDS), Supplemental submissions, and regulatory pathway strategy for Canadian market access.
Strategic regulatory roadmapping — identifying the most efficient global submission sequence, timeline planning, gap analysis, and cross-agency correspondence management.
Structured risk assessments, regulatory intelligence monitoring, compliance gap identification, and mitigation planning across GxP, GMP, and GDP frameworks.
Variation management, label updates, safety submissions, and post-market surveillance reporting to maintain regulatory compliance throughout the product lifecycle.
Research and development within GMP regulatory frameworks — from early formulation design and technology development through to scale-up, technology transfer, and manufacturing excellence.
Dosage form development — oral solid, liquid, semi-solid, and parenteral formulations — designed within regulatory frameworks and aligned with target product profiles for specific market requirements.
Structured technology transfer programmes from originator to manufacturing site — including process characterisation, scale-up documentation, and cross-functional team integration across R&D and manufacturing.
Manufacturing process optimisation within GMP and QMS frameworks — including process validation, cleaning validation, and continuous improvement methodologies to maximise product quality and yield.
Analytical method development and validation, specification setting, and stability programme design in accordance with ICH guidelines and regulatory requirements.
Expert scientific support for formulation and manufacturing challenges — root cause analysis, CAPA implementation, regulatory deviation management, and technical solutions for approval pathway obstacles.
Chemistry, Manufacturing and Controls (CMC) documentation preparation — Module 3 content, process descriptions, batch analyses, and stability data compilation for regulatory submissions globally.
Patent strategy and IPR management to protect, strengthen, and maximise the commercial value of pharmaceutical innovations across global markets.
Strategic IP portfolio development — identifying patentable innovations, maximising protection coverage, and aligning patent strategy with global market entry and commercialisation timelines.
Comprehensive FTO analysis to identify potential patent risks before product launch — enabling informed go/no-go decisions and alternative formulation or development strategies.
In-depth patent landscape analysis integrating technology and patent paradigms — identifying white space opportunities, competitive threats, and strategic opportunities for pharmaceutical innovation.
End-to-end intellectual property rights management including registration, maintenance, licensing arrangements, and enforcement strategy across multiple jurisdictions.
Strategic identification of licensing opportunities — integrating technology trends, patent paradigms, and market dynamics to surface acquisition, in-licensing, and partnership opportunities.
Technology and patent-driven competitive intelligence to inform R&D investment decisions, product development prioritisation, and market entry strategy.
Strategic pharmaceutical project management designed to accelerate market entry, optimise regulatory pathways, and drive successful commercialisation outcomes.
Comprehensive project oversight from initial concept through development, regulatory submission, approval, and market launch — with structured governance, milestone tracking, and escalation protocols.
Integrated submission timeline planning, agency meeting coordination, and cross-functional team alignment to ensure regulatory milestones are achieved on time and within budget.
Seamless coordination across R&D, manufacturing, regulatory, commercial, and supply chain functions — ensuring cohesive programme delivery across geographically distributed teams.
Structured risk identification, assessment, and mitigation planning — with compliance checkpoints built into every project phase to prevent costly regulatory deviations or delays.
Real-time project monitoring through regulatory approval and commercialisation, with transparent stakeholder reporting, KPI dashboards, and issue escalation procedures.
Market analytical data packages integrated into project strategy — enabling commercial viability assessments, competitive positioning, and launch readiness planning aligned with regulatory timelines.
Innovation & Technology
Our services are underpinned by advanced digital platforms and flexible outsourcing models that deliver greater speed, accuracy, and adaptability for evolving pharmaceutical market demands.
Advanced digital platforms for regulatory intelligence gathering, market analytics, and project monitoring — enabling data-driven decision-making across complex multi-market pharmaceutical programmes with real-time visibility.
Customised service packages aligned with your organisation's specific needs, scale, and budget — from full-service programme partnerships to targeted specialist support for individual project phases or regulatory submissions.
