Regulatory Affairs
What makes us different
Clinigen are a global regulatory service provider that supports clients through the clinical and post-marketing phases of the medicine lifecycle. Our ability to hold marketing authorisations and our deep hands-on experience working across both the unlicensed and licensed phases means we stand apart from other regulatory service providers. Our team of experts working across Europe, US, Africa, Australia/New Zealand and Asia supported by a network of consultants are a true one-stop-shop for our pharma clients at a country and regional level.
Clinigen have more than 30 years’ experience supporting access to both unlicensed and licensed medicines into more than 160 countries across a range of therapy areas including oncology, CNS and orphan and rare diseases. Clinigen also have a proven track record of successfully applying for and maintaining the marketing authorisations for numerous products across the globe and support our clients in strategic decisions on where and how to register and commercialise their products to meet their aims.
Services
REGULATORY STRATEGY | Clinigen’s regulatory consultancy services provide our clients with a blueprint that will guide them to their desired destination. Whether it is the unlicensed-to-licensed strategy, gap analysis, submission strategy or product acquisition due diligence, the Clinigen team will provide direction from development to launch and beyond. |
Regulatory Intelligence | The world of regulatory intelligence is complex and differs from country-to-country and product-to-product. Clinigen’s regulatory intelligence spans both unlicensed and licensed medicines and can be accessed by our clients on a global, regional or country level ensuring they remain compliant at all stages of the lifecycle. Clinigen can provide regulatory intelligence and interpret it for your specific needs. Clinigen can also create impact assessments of upcoming changes to ensure our clients can capitalize on changes in the regulatory environment. |
Regulatory Submissions | The Clinigen team supports all types of submissions across the lifecycle in multiple markets. This starts in the clinical phase including clinical trial applications, orphan drug designation applications, fast track designations, Early Access submissions, paediatric plans and continues into the commercial phase with marketing authorisation applications. Our in-house publishing team gives flexibility and highest quality of output. |
Marketing Authorisation Holding and Maintenance | Clinigen hold and maintain more than two hundred marketing authorisations across Africa, Europe, US, UK, Australia/New Zealand and South East Asia on behalf of our pharma clients. We also have a wealth of expertise in marketing authorisation transfer and can offer a complete back-office solution ensuring all licence maintenance and associated activities are addressed. Our team provides exploitant services for France and Responsible Pharmacist services for ZA and Japan. |
Global Experts
Our experts around the world combine global perspective with local expertise. Meet some of the team that will support you:
Merav is an experienced regulatory affair professional with over 25 years working within pharma and consultancy companies. Merav has a pharmacy background and she leads the global regulatory affairs team at Clinigen overseeing delivery of global projects and development and growth of the team.
With a background in medicinal chemistry (PhD), Melanie has over 15 years’ experience in regulatory affairs within pharma and consultancy. Melanie specializes in regulatory strategy and execution in product acquisition, authorisation and licence optimisation.
Elizabeth has extensive understanding of the complex environment of unlicensed medicines and early access, having worked in this field for over 10 years. Elizabeth advises pharmaceutical and biotech companies on regulatory strategies and compliance throughout Managed Access Programmes to enable best outcomes in product development and patient access.
With a background in pharmacy and business school, Julie has 20 years’ experience in the pharmaceutical field, working in large- and small-sized companies. Julie has been involved in product development at different stages and is now leading the pharmaceuticals activities (Regulatory, Quality, Pharmacovigilance and Medical Information) at Clinigen’s French site.
With over five years’ experience in regulatory affairs, electronic submissions and data management, Joerg is an eCTD publishing specialist for all eCTD-relevant regions. He has in depth experience with all types of applications including MAAs, variations, renewals. In addition, Joerg is well versed in the eCTD publishing tools from both leading software manufacturers as on-premise and cloud-based solutions.
Yuka Umemura is a licensed pharmacist with over 18 years of regulatory experience in biopharmaceutical/chemical molecule development, regulatory communication with PMDA/MHLW and strategy across diverse therapeutic indications. Yuka specializes in Quality/CMC, IND/CTN, clinical trials, J-NDA submission, life-cycle management, GMP compliance application, inspections for external manufactures and external PV vendor under Japan Pharmaceutical and Medical Device (PMD) Act.
Danielle is an experienced regulatory professional having worked in pharmaceutical industry for 9 years. Danielle has a pharmacy background and leads the Asia Pacific regulatory team. She has extensive experience in developing regulatory strategies and providing regulatory advice to support new product launches and business development opportunities. Danielle has been involved in the registration, maintenance, and oversight of a broad range of therapeutic areas and products across the Asia Pacific region.
Hagyeong majored in biotechnology and has been working in the pharmaceutical manufacturer and importer business for 7 years. Hagyeong’s expertise is in GMP and GDP regulation and she specializes in regulatory compliance in product registration, variation, and quality management.
Jeanne is a pharmacist with over 24 years’ experience in the pharmaceutical sector. As Responsible Pharmacist, her main responsibility is to comply with the duties as set out in the South African Pharmacy Act and the relevant sections of the Medicines Act (Act 1010 of 1965) and to ensure compliance of the business in terms of the same. In addition Jeanne and her team support registration of new products, dossier maintenance, compliance and supply chain protection in South Africa and the rest of Africa in partnership with various international Principals. Jeanne is also responsible for advertising/marketing approvals in South Africa.
Case studies
- Regulatory Strategy
- Regulatory Submissions
- Marketing Authorisation Holding and Maintenance
Indication Dynamics: Strategic response to generic competition due to altered therapeutic landscape for a US originator product.
Situation/Problem
A US originator product faced generic competition in market from products with the same active ingredient but different indication. The originator product was authorized for use in a rare indication, the generic product was authorized in a more prevalent indication, impacting market share.
Solution
Clinigen developed an indication-expansion strategy for the originator product, de-risking the strategy via FDA agency advice, obtaining a full PSP waiver and submitting a successful efficacy supplement to authorize a second indication without the need for additional clinical studies.
Value to client
As an originator product with dual indications, the client achieved an approval that was distinct in the market and protected from direct generic competition. This was achieved without costly studies, and with no post-approval commitments.
Navigating Objections: A case study on well-established use in a decentralized procedure for bibliographic marketing authorisation.
Situation/Problem
During a decentralised procedure for a bibliographic marketing authorization application (11 member states), concerned member states raised objections to the well-established use of the proposed indication.
Solution
Clinigen successfully justified the well-established use of the indication in Europe by providing evidence that verified the continuous clinical use of the product in Europe in the proposed population and indication, and defended its position in a breakout session with the regulatory agencies.
Value to client
Approval of the product was gained despite initial negative opinion from several member states.
Breaking Barriers: Expanding market presence in Asia-Pacific through strategic partnership and product commercialisation.
Situation/Problem
A client based in the EU needed a partner to register and commercialise their product in Asia-Pacific (APAC) markets, where they had no local entities.
Solution
Link (A Clinigen Company) provided full registration, compliance and commercialisation services in APAC markets, acting as the MAH in countries where the EU partner did not have an entity. The RA team developed and executed the regulatory strategies for APAC expansion utilising the EU dossier and approval for the relevant expedited and orphan registration pathways.
Value to client
Link (A Clinigen Company) provided a one partner solution for the APAC region. By having a trusted partner in APAC, the client was able to leverage our know-how for a successful and resource efficient expansion into these markets.
Global Stewardship: Navigating regulatory landscapes for sustained registration and compliance of a mature hospital-use parenteral product.
Situation/Problem
Requirement to maintain a mature hospital-use parenteral product registered nationally in more than 20 countries including EU, US, Japan and RoW markets.
Solution
Clinigen ensured maintenance of all licences by maximizing harmonisation and compliance across all regions with regards to product information and Module 3 changes. Clinigen gained new licences in RoW markets to support commercial activities and supported supply to markets where patients required access through unlicensed routes. Generic defense strategies were prepared and executed over the years in line with commercial requirements.
Value to client
The product continues to provide high revenue to the client despite availability of generic versions, in both established and new markets.
Balancing Access and Viability: Overcoming commercial challenges in supplying essential low-volume medicines across Asia-Pacific markets.
Situation/Problem
A US pharma company had a low volume product that was considered an essential medicine. Due to its low cost, it was not commercially viable to supply local pack in each Asia-Pacific (APAC) market to meet patient needs.
Solution
Link (A Clinigen Company) provided a regulatory strategy for APAC markets, utilising foreign pack with minimal over-labelling performed by Link’s GMP approved secondary packaging facility in Singapore. As Link were the single regulatory contact point across the markets, the compliance variation submissions were streamlined and resource impact on the client was minimised.
Value to client
Link (A Clinigen Company) implemented a commercially viable solution to maintain supply of this low volume, essential medicine in APAC markets on behalf of the client.