Comprehensive regulatory affairs consultancy solutions for pharma and biotech companies

PhaRA can take ownership of specialised regulatory activities and deliverables for pharma and biotech companies, or even function as a fully-staffed EU or BENELUX regulatory affairs department (eg, act as head of Regulatory Affairs for start-up companies or provide a ‘virtual’ regulatory department for small/medium-sized companies). We advise on drug development and regulatory strategies, submit your applications, run your procedures, liaise with health authorities.

We can prepare for EMA or national scientific advice, orphan drug designation (ODD), pediatric investigation plan (PIP), clinical trial application (CTA), marketing authorisation application (MAA), including strategic advice, regulatory scientific writing, and procedural support (CP/DCP/MRP) for initial filing or during life cycle management.

Therapeutic areas of special interest include infectious diseases and vaccines, immunology, oncology, neuroscience, and other unmet medical need areas.

Temporary regulatory affairs staffing for pharma and biotech companies

We offer temporary onsite staffing solutions for companies located in Belgium and the Netherlands during prolonged sickness, maternity leaves, holidays, or while awaiting a permanent hire. We complement existing resources at international headquarters or BENELUX affiliates to cope with workload peaks or to bridge a period of uncertainty due to staff shortage by sharing our talented regulatory affairs professionals. Our senior consultants can act ad interim as head of Regulatory Affairs.

Senior advisory board of key RA opinion leaders

PhaRA offers Senior Advisory Services to support clients with regulatory strategy and decision-making. Our senior advisors bring decades of experience from leadership roles within pharmaceutical companies and regulatory agencies, offering a unique perspective that combines industry insight with regulatory authority expectations. Clients benefit from their top-notch expertise in shaping regulatory strategies, managing complex development programs, and navigating interactions with health authorities. Whether you need strategic input at key milestones, advice for regulatory risk assessment, or guidance during critical agency meetings, PhaRA’s senior advisors offer a trusted sounding board tailored to your unique needs.

Georgianna Harris

Georgianna Harris is a US-based biochemistry PhD and seasoned Regulatory Affairs consultant with over 30 years of experience spanning drug discovery, global drug development, FDA interactions, registration and life-cycle management of both small molecules and biologics. She has held senior leadership roles including Senior Vice President of Regulatory Affairs at Alkermes and Executive Director at Merck.  Her career is distinguished by a strong track record of successful global product approvals and life-cycle strategies across therapeutic areas such as neuroscience, addiction, diabetes, obesity, women’s health, and oncology. She brings deep expertise in drug development, global and US regulatory affairs, due diligence for licensing and acquisitions, and is known for her collaborative leadership style, strategic insight, and ability to build high-performing teams.

Karin Van Baelen

Karin Van Baelen is a seasoned expert in drug development, global regulatory affairs, and organizational leadership, with over 35 years of experience in the pharmaceutical industry. As the former Head of Global Regulatory Affairs at Janssen, the pharmaceutical companies of Johnson & Johnson (now J&J Innovative Medicines), Karin led a global team of 1,200 professionals until April 2023. Under her leadership, Janssen achieved over 20 global medicine approvals across key therapeutic areas including oncology, neuroscience, immunology, cardiovascular-metabolism, retinal disease, and infectious diseases including vaccines.  Karin played a pivotal role in shaping regulatory strategies, ensuring timely and high-quality submissions, and fostering strong relationships with Health Authorities worldwide. She has also been actively involved in national and international policy development in regulatory science, biotechnology, and clinical development. Karin leverages her wealth of experience and ‘this is how we can’ mindset to translate strategic global regulatory insights, organizational effectiveness, and leadership consulting into tangible business success.

Koen Norga

Koen Norga is a practicing paediatrician and physician-scientist with extensive regulatory experience in medicines development.  He was Chair of EMA’s Paediatric Committee (PDCO) and an active member of different EMA scientific committees and working parties (PDCO, CHMP, SAWP, Oncology WP, Extrapolation WP) for over 10 years. After training in Paediatrics at Boston Children’s Hospital / Harvard Medical School and in Paediatric Haematology/Oncology and Molecular & Human Genetics at Texas Children’s Hospital and Baylor College of Medicine, where he also obtained a PhD in Molecular & Human Genetics, he returned to University of Leuven, his alma mater, as a staff physician in the Paediatric Oncology division. In 2012 he went on to lead the Paediatric Oncology unit at Antwerp University Hospital. In 2023, he transitioned to general paediatric practice at Tienen community hospital.  Currently he combines clinical work as a general paediatrician at az West, a community hospital, and as a paediatric haematology consultant at Brussels University Hospital (UZB-VUB) with his role as a senior advisor at PhaRA.  In his consultancy role, he engages in advising on both regulatory and medical aspects of medicines development, with a particular focus on treatments for children and rare diseases.

Writing expertise and support

Through its writing expertise, PhaRA can support or take ownership of writing activities on behalf of pharma and biotech companies for clinical trial related documents and deliverables including protocols, summary documents, clinical study reports, etc. PhaRA’s support can apply to larger companies by providing support to their existing Medical Writing departments as well as to small/medium-sized companies by acting as a ‘virtual’ Medical Writing department or by taking on the role of head of Medical Writing.

TAILORED REGULATORY AFFAIRS INTELLIGENCE SERVICES, TRAINING, WORKSHOPS, AND HELPDESK SUPPORT FOR VARIOUS REGULATORY NEEDS

PhaRA can provide in-house RA training tailored to the client needs and organisation, e.g., train newly hired junior staff, train US clients to gain insight in the EU regulatory frame and navigate the regulatory landscape, personal coaching and assistance with specialised subject matters (e.g., first time to handle a scientific advice, prepare for an agency meeting, write a PIP, apply for orphan drug status, etc.). The interactive training approach allows participants and PhaRA’s expert trainer to share experiences and address common issues faced in everyday regulatory practice.

We also offer regulatory ‘helpdesk’ support for clients who wish to consult us on a regular basis for imminent regulatory questions. Our helpdesk services offer flexible, on-demand access to seasoned regulatory experts, giving them the confidence to move forward with informed decisions.

PhaRA provides expert regional content on Belgium and Luxembourg for Cortellis™ Regulatory Intelligence. Clarivate Analytics professional regulatory intelligence specialists work with an international network of consultants, each with an in-depth local expertise. As a result, each Cortellis™ Regulatory Intelligence country module contains detailed and continuously updated Regulatory Summaries written by experts from the region.