Regulatory Affairs Services
Global expertise across the full product lifecycle from development to market access
At Nexus Pharma Group, we partner with pharmaceutical and medical device organisations worldwide to navigate the complex and evolving global regulatory landscape.
Our regulatory experts support your products through every phase from pre-submission planning to post-approval compliance ensuring alignment with ICH, EMA, FDA, MHRA, Health Canada, and WHO standards.
We translate regulatory complexity into clear, compliant strategies for global success.
We are expert in providing regulatory consulting services for Pharmaceuticals as well Medical devices.
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Pharmaceutical Regulatory Services
Accelerating approvals while maintaining uncompromising compliance
Our pharmaceutical regulatory team provides strategic, scientific, and operational support for human medicinal products, biologicals, and advanced therapies. We ensure your submissions meet global requirements while minimising time-to-market
Regulatory Strategy & Pathway Development
- Strategic advice on clinical development plans, registration routes (NDA, ANDA, MAA, CTA, IND, BLA), and global harmonisation.
Dossier Preparation & Electronic Submission (eCTD / NeeS)
- Support for new product approvals, line extensions, variations, and renewals across multiple territories.
Product Registration & Lifecycle Management
- Development and harmonisation of SmPC, PIL, and prescribing information aligned with EMA/FDA standards.
Labeling & Product Information
- Development and harmonisation of SmPC, PIL, and prescribing information aligned with EMA/FDA standards.
Regulatory Intelligence
- Continuous monitoring of changing regulations and guidance to keep your product portfolio compliant.
Post-Approval & Maintenance Activities
- Management of variations, renewals, annual reports, and pharmacovigilance integration.
Authority Interaction & Representation
- Communication with competent authorities (FDA, EMA, MHRA, Health Canada, etc.) to facilitate efficient reviews and responses.
Our approach blends regulatory science with operational excellence enabling faster, safer, and more sustainable product launches.
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Medical Device Regulatory Services
Helping innovators achieve and maintain compliance across global markets.
From early development to post-market surveillance, we support medical device and in-vitro diagnostic (IVD) manufacturers through every regulatory milestone. Our experts are fluent in international frameworks including EU MDR / IVDR, US FDA 21 CFR Part 820, UK MDR 2002, Health Canada CMDR, and ISO 13485.
Regulatory Strategy & Classification Guidance
- Determining appropriate classification and conformity route across multiple jurisdictions.
Technical Documentation & Design Dossiers
- Preparation and maintenance of technical files, clinical evaluations, risk management (ISO 14971), and essential principles.
Global Market Access & Registration
- Support for CE marking, US FDA 510(k)/De Novo/PMA submissions, UKCA, Health Canada licensing, and international registrations.
Labelling, IFU & Packaging Compliance
- Development and review in line with ISO 15223-1, IEC 62366, and GHTF labelling guidance.
Quality Management System (QMS) Support
- Implementation and auditing of ISO 13485 and FDA QSR-compliant systems.
Post-Market Surveillance & Vigilance
- Design of PMS and PMCF plans, complaint handling, trend analysis, and adverse event reporting.
Change Control & Regulatory Impact Assessment
- Evaluation and documentation of design/manufacturing changes requiring notification or re-submission.
Training & Audit Preparation
- Tailored training for regulatory teams and readiness assessments for notified body or authority inspections.
We help device innovators cross borders confidently compliant, audit-ready, and patient-focused.