Regulatory requirements for product registration can be overwhelming. They’re complex, vary by country, and frequently change. We know they’re important (safe medicines, yes!), but what does it actually take to get a product from the manufacturing plant onto the shelves in your local pharmacy? Let’s take a look together.
Comprehensive Regulatory Support
Comprehensive Regulatory Support
The regulation of health products is a critical component of strong health systems, as it promotes and protects public health through controlling the safety and efficacy of products (pharmaceuticals, medical devices, etc.) and through regulating the companies that develop, manufacture, and market these products to the public.
Catalyst Global provides support to bring a product to market in alignment with the local regulatory requirements anywhere in the world. With ever-changing and diverse regulatory environments, complex application requirements, and increasing development costs and timelines, Catalyst Global ensures regulatory compliance from product development (research, non-clinical, and clinical) through the registration, distribution, marketing, and post-market surveillance of regulated products. Our team also helps developers to evaluate products still in early stages of development or which are being assessed for additional indications.
Since 2010, Catalyst Global has successfully managed over 160 registrations of drug products and medical devices in over 90 countries.
What we do
- Strategy: we provide technical leadership and guidance in Regulatory Affairs to support all areas of the regulatory life cycle, including program development, evaluation, scientific advice, and strategic regulatory planning.
- Practice: we offer both comprehensive and a la carte regulatory services to support market strategy, landscape assessments, dossier compilation and publishing, full product registration applications, regulatory intelligence, regional harmonization filings, regulatory project management, trademark support, WHO prequalification, and more.
- Clinical trial assistance: we support clinical trial and pre-market activities through evaluation of clinical trial preparedness to meet country-specific regulatory requirements, protocol and ethics board submissions, protocol amendments, and site monitoring.
Examples of regulatory support projects include:
- Registration support to Medicines 360 for its AVIBELA Hormonal IUD
- Registration support to MSI Reproductive Choices for its portfolio of reproductive health products
- Support to DKT International/DKT WomanCare for post-approval variations of its medical device in over 16 countries
- Registration support to Evofem Biosciences/Mann Global Health for Femidence™, a hormone-free contraceptive gel
- Collaboration with Mann Global Health on – Landscape Assessment for RHSC: Leveraging the role of national distributors to increase access to medical abortion combi-packs in Africa
Over 16 different products, including drug products (hormonal IUS, hormonal vaginal rings, emergency/oral contraceptives, medical abortion, etc.) and medical devices (IUDs, diaphragms, vaginal gels, colposcopes, ultrasound devices, manual vacuum aspiration system, etc.).
“Wilberto and his team have provided valued regulatory support to registrations in the LAC region as part of our global variation process for our MVA medical device. They have strong language skills and are a pleasure to engage with as well as being well versed on local regulatory requirements in the region.”
Tracey Brett, RA Director
DKT WomanCare Global
Reports and Publications
EECO Regulatory Guide
- English – EECO-Regulatory-Guide
- French – EECO-Regulatory-Guide_French
- Portuguese – EECO-Regulatory-Guide_Portuguese
- Spanish – EECO-Regulatory-Guide_Spanish
Leveraging the role of national distributors to increase access to MA combi-packs in Africa. Mann Global Health Report to RHSC. (Jan 2019) https://www.rhsupplies.org/uploads/tx_rhscpublications/Landscape_Assessment_Combi-Packs_RHSC_01.pdf
Product Registration: Pro Tips for Program Managers (May 2019) – https://www.psi.org/2019/05/product-registration-pro-tips-for-program-managers/
“Contraceptive product registration: regional harmonisation through the East African Community mechanism.” (June 2023). https://www.regulatoryrapporteur.org/contraceptive-product-registration-regional-harmonisation-through-the-east-african-community-mechanism/246.article?adredir=1
“African Medicines Regulatory Harmonization” White Paper. (April 2017). White-Paper-on-Africa-Harmonization-Initiatives-FINAL-041817-1
Product Registration Toolkit
Visit our Product Registration Toolkit page for guides, checklists, templates and much more. https://catalystglobal.org/2022/06/14/eeco-product-registration-toolkit/
The Product Registration Toolkit is a digital collection of adaptable resources to guide the process of registering health products, like contraceptives, in low- and middle-income countries.
The goal of the Market Access Accelerator is to support commercial partners to bring new, innovative sexual and reproductive health products to market in low- and middle-income countries.