We regularly support clients in understanding applicable legislation and regulatory requirements. Our value lies in the interpretation and practical application of these requirements across multiple regulatory authorities. Orphan Drug Consulting provides a full suite of Quality Assurance services across both clinical and commercial activities. We take a patient-first approach to Quality Assurance, ensuring governance and decision-making consistently support the safe and effective supply of medicines. Our cross-functional approach ensures alignment across teams, enabling smoother implementation and sustained compliance.
We carry out comprehensive gap assessments of existing Quality Management Systems (QMS) against global and local regulatory requirements. The assessment identifies deficiencies, areas for improvement, and any non-compliances requiring urgent attention. The outcome is a clear and actionable plan to close gaps and strengthen compliance, while leveraging existing systems and processes wherever possible.
A robust Quality Management System (QMS) is fundamental to ensuring products meet regulatory requirements and customer expectations. We support the implementation and enhancement of QMS frameworks that comply with the requirements of regulatory authorities such as the FDA and EMA, including Good Manufacturing Practice (GMP) obligations. Key elements of the system include document control, risk management, change management, and corrective and preventive actions (CAPA). Our approach begins with a detailed review of the client's existing quality system, ensuring that previous work is built upon. We then implement targeted updates to create a system that is compliant, robust, and tailored to support the specific needs of each organisation.
We support clients in identifying and obtaining the licences required to support manufacturing and distribution activities. This includes managing the Wholesale Distribution Authorisation (WDA) application process in a structured and efficient manner. Our support covers application preparation and submission, inspection readiness, hosting of inspections, and liaison with regulatory authorities, ensuring the process is aligned to your organisation's needs and leads to a successful outcome.
Where a Swiss entity is in place, a Pharmaceutical Establishment Licence (PEL) may be required. We support clients in identifying the correct licence categories and managing the acquisition process efficiently. Our end-to-end service includes engagement with Swissmedic, application preparation and submission, inspection readiness, and inspection hosting, delivered in the local language by experienced team members.
Marketing Authorisation Holder obligations are critical to ensuring compliant and uninterrupted supply of medicines. As the legal entity responsible for the authorisation, the MAH is accountable for compliance with Pharmacovigilance, Good Manufacturing Practise (GMP), and Good Distribution Practise (GDP) requirements. We support clients in meeting these obligations and in interactions with regulatory authorities.
The Responsible Person (RP) plays a key role in ensuring compliant and effective supply. This requires a detailed understanding of applicable legislation across relevant jurisdictions and the ability to engage confidently with regulatory authorities. Our consultants act as Responsible Persons and Functional Responsible Persons across multiple European markets.
We provide Qualified Person services for commercial products, supporting regulatory compliance, GMP oversight, batch release, auditing, staff training, and regulatory submissions. Orphan Drug Consulting holds a Manufacturer's/Importer's Authorisation (MIA) and a MIA for Investigational Medicinal Product (MIA for IMP) from the HPRA in Ireland.
We provide Qualified Person (QP) services to support the compliant manufacture, release, and supply of investigational medicinal products during clinical development. Our QP services include regulatory compliance support, GMP oversight, QP batch release of clinical product, Quality Assurance support, auditing, staff training, and assistance with regulatory submissions.
We support organisations in maintaining inspection readiness through audits and inspection preparation activities. Our experience spans clinical, manufacturing, and distribution audits across multiple regulatory authorities, including FDA, EMA, PMDA, and ANVISA. We conduct internal audits, mock inspections, targeted training, and support inspection hosting roles.
Quality and Technical Agreements (QTA) have become increasingly important in recent years, with many regulatory inspections now beginning with their review rather than standard operating procedures. In an outsourced operating model, QTAs are the key documents governing responsibilities between organisations and their vendors and are critical to maintaining compliance.
Our quality assurance services ensure your organisation maintains the highest standards of compliance and patient safety.
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