As a Marketing Authorisation holder (MAH) you are facing a complex regulatory landscape, with a wide range of responsibilities and requirements.
To help you navigate, we offer a team of regulatory and compliance experts, selected for their specific knowledge, management skills, and vast experience in consulting.
We offer a wide range of expert services for Marketing Authorisation holders, with experienced project managers and subject matter experts to support you.
New Marketing Authorisation Applications (MAA)
Bringing a new pharmaceutical product to market requires a structured and strategic approach to regulatory submissions. An experienced project manager, supported by Regulatory Affairs, CMC, and Pharmacovigilance experts, ensures the submission process runs smoothly, avoiding costly delays and compliance risks.
Key challenges include compiling dossiers that meet stringent EMA, MHRA, and Swissmedic requirements, aligning clinical and CMC data, and responding effectively to regulatory queries.
A dedicated project manager oversees timelines, coordinates cross-functional teams, and proactively mitigates risks, ensuring the MAA is submitted on time and approved with minimal obstacles.
Variations and lifecycle management
Pharmaceutical products require continuous updates, whether due to manufacturing changes, new indications, or safety updates. Managing variations across multiple markets is complex and time-sensitive, requiring expert coordination.
A project manager, supported by Regulatory Affairs and CMC specialists, ensures smooth handling of Type IA, IB, and II variations, coordinating with manufacturing, safety, and quality teams. They anticipate regulatory authority expectations, avoiding rejections and ensuring compliance.
Expansion into new markets
Entering new markets requires in-depth knowledge of local regulations, reimbursement systems, and compliance requirements. Without a structured approach, companies risk delays, compliance failures, and lost market opportunities.
A dedicated project manager, working with local regulatory and market access experts, ensures a seamless expansion strategy by managing local registration, pricing, and compliance requirements. They develop tailored submission strategies for each market, ensuring efficient approvals.
GDP and supply chain
Pharmaceutical supply chains are complex and highly regulated. Changes to manufacturing, distribution, or suppliers must be carefully managed to avoid compliance issues and market shortages.
A supply chain project manager, working with regulatory and quality teams, ensures efficient planning and execution of CMC variations, tech transfers, and supply continuity strategies.
Pharmacovigilance
Ensuring drug safety compliance is a legal and ethical responsibility, requiring a structured pharmacovigilance (PV) system. Without proper oversight, companies risk regulatory action, reputational damage, and patient safety concerns.
A pharmacovigilance project manager, supported by risk management and compliance specialists, ensures a fully operational PV system that meets EU and UK GVP requirements. They establish QPPV oversight, risk management plans, and robust reporting systems.
GMP compliance and audits
Regulatory inspections and GMP compliance are critical to maintaining market authorisation and ensuring product safety. Regulatory non-compliance can lead to production halts, supply chain disruptions, and product recalls.
A project manager, backed by Quality Assurance and GMP auditors, ensures a comprehensive compliance strategy by identifying potential gaps, coordinating remediation efforts, and preparing teams for inspections. This proactive approach reduces regulatory risk and prevents costly disruptions.
Technology Transfer
Whether transferring from R&D to full-scale production, shifting to a new contract manufacturer (CMO), or scaling up to meet global demand, an efficient and compliant transfer process is essential to maintain product quality, regulatory compliance, and supply continuity.
With experienced project managers and experts in CMC, GMP, and Quality Assurance, we help pharmaceutical companies mitigate risks, accelerate timelines, and maintain regulatory compliance.
Mergers, acquisitions, and due diligence
Pharmaceutical mergers and acquisitions (M&A) involve regulatory, quality, and pharmacovigilance risks that must be thoroughly assessed. Failing to identify risks early can result in unexpected compliance issues, legal liabilities, and operational setbacks.
A project manager, supported by due diligence specialists, ensures a structured risk assessment of regulatory compliance, product registrations, and quality systems. They provide clear recommendations to mitigate risks before and after acquisition.
Market Access
Successful market entry depends not only on regulatory approval but also on achieving favourable pricing and reimbursement. A misaligned strategy can lead to pricing delays, poor reimbursement, and limited market uptake.
A market access project manager, working with health economics and reimbursement experts, ensures a clear strategy for payer negotiations, HTA submissions, and value demonstration. By aligning early with regulatory and clinical development, companies can optimise pricing outcomes and patient access.
Regardless of whether manufacturing is conducted in-house or outsourced to a Contract Manufacturing Organisation (CMO), the MAH retains full legal responsibility for ensuring compliance with regulatory, quality, safety, and pharmacovigilance requirements. Arex offers experienced specialists to ensure that all your responsibilities are fulfilled.
MAH responsibilities in in-house manufacturing
When the MAH also operates its own manufacturing facility, additional responsibilities include:
Direct manufacturing oversight
Direct quality ocntrol & batch release
Site & equipment maintenance
MAH responsibilities in outsourced manufacturing
When the MAH outsources production to a CMO, it must ensure appropriate oversight and compliance, despite not being directly involved in production.
Contract management & CMO oversight
Regulatory & quality control oversight
Risk management & issue resolution
Our team has experience from working with different types of products, in a range of global regulatory functions, at all stages of the product lifecycle.
Read more about our services
Erik Hedner
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
