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.
Worldwide
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.”
Recent collaborators
Recent collaborators
Reports and Publications
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
Visit our Product Registration Toolkit page for guides, checklists, templates and much more. https://catalystglobal.org/2022/06/14/eeco-product-registration-toolkit/
Related posts
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.
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.