Partner With Us
Galenica Health is your strategic partner for accessing the dynamic healthcare market in the Americas. Specializing in supplying Finished Drug Formulations (FDFs) and cutting-edge medical devices, we are committed to addressing unmet medical needs and improving patient outcomes across the region. With a proven track record of success, we have played a pivotal role in expanding access to diverse, innovative drugs, biological products, specialty generics, and orphan drugs throughout our region.
As we continue to lead in this market, we invite pharmaceutical companies seeking to broaden their reach to collaborate with us. With our extensive portfolio and unparalleled expertise, we offer a comprehensive solution for commercialization, leveraging our robust logistics and supply chain network and deep local market knowledge.
Partnering with Galenica means accessing a cost-effective, end-to-end commercialization solution, enabling your products to thrive in new markets beyond your current reach. Join us in shaping the future of underserved communities and participate in government and non-government initiatives to expand access to critical medicines.
Dossier Development
Galenica is the leading Regulatory Service Provider, delivering comprehensive regulatory affairs services focusing on Dossier Development. Our tailored approach begins with a meticulous gap analysis of your dossiers, ensuring submission-ready filings that meet the highest standards.
We offer various services, including independent document development, translation, and adaptation of existing documents to align with local submission requirements. Our commitment to excellence is reflected in our best-in-class regulatory affairs services, which encompass in-country development and adaptation of clinical data, as well as a thorough gap analysis of existing dossiers.
Backed by a team of seasoned experts with extensive knowledge of National Regulatory Agencies’ laws and policies, we provide unparalleled regulatory support. Our technical experts remain vigilant, continuously monitoring new regulations and guidelines to adapt real-time submissions, ensuring complete compliance.
Dossier Development
Galenica is the leading Regulatory Service Provider, delivering comprehensive regulatory affairs services focusing on Dossier Development. Our tailored approach begins with a meticulous gap analysis of your dossiers, ensuring submission-ready filings that meet the highest standards.
We offer various services, including independent document development, translation, and adaptation of existing documents to align with local submission requirements. Our commitment to excellence is reflected in our best-in-class regulatory affairs services, which encompass in-country development and adaptation of clinical data, as well as a thorough gap analysis of existing dossiers.
Backed by a team of seasoned experts with extensive knowledge of National Regulatory Agencies’ laws and policies, we provide unparalleled regulatory support. Our technical experts remain vigilant, continuously monitoring new regulations and guidelines to adapt real-time submissions, ensuring complete compliance.
GMP-Certificate
Pre-audit preparation
Companies seeking to market pharmaceutical products in countries across the Americas must obtain certification from the respective regulatory authorities. Compliance with current Good Manufacturing Practices (cGMP) standards is imperative, encompassing a spectrum of requirements from recognition of certifications issued by foreign authorities to certifications obtained from local authorities following rigorous inspections.
Certification may entail plant inspection for finished drug products, intermediates, or active pharmaceutical ingredients (API). These inspection and certification processes may require time for regularization, potentially extending project timelines. As such, thorough preparation and adherence to GMP standards are essential for ensuring compliance and facilitating smooth regulatory approval processes.
Product Registration
Galenica is a results-oriented organization with a proven track record of successfully registering numerous pharmaceutical products and services across the Americas. Leveraging our extensive network of local offices and expert teams, we offer unparalleled support and guidance throughout the registration process.
Our dedicated teams possess in-depth knowledge of the regulatory landscapes in each country, ensuring a seamless registration experience. From navigating complex requirements to facilitating communication with regulatory authorities, we are committed to delivering efficient and effective solutions for our clients.
Product Registration
Galenica is a results-oriented organization with a proven track record of successfully registering numerous pharmaceutical products and services across the Americas. Leveraging our extensive network of local offices and expert teams, we offer unparalleled support and guidance throughout the registration process.
Our dedicated teams possess in-depth knowledge of the regulatory landscapes in each country, ensuring a seamless registration experience. From navigating complex requirements to facilitating communication with regulatory authorities, we are committed to delivering efficient and effective solutions for our clients.
Pharmacovigilance
As defined by the World Health Organization, pharmacovigilance encompasses the science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other possible drug-related problems. With a wealth of experience in pharmacovigilance, Galenica Health boasts a proven track record of consistently delivering high-quality and compliant services tailored to each product and territory.
Our comprehensive monitoring and compliance system is designed to uphold the highest compliance standards throughout our products’ commercial lifecycle. As your dedicated monitoring and compliance partner, Galenica Health ensures meticulous handling of all relevant actions and reporting, adhering rigorously to local regulatory guidelines.
Brand Registration
Trademark registrations in our region require filing within each jurisdiction, which comes with individual requirements and laws. Galenica Health boasts of having registered dozens of products and businesses across the area due to our country-specific understanding of each market’s local requirements, laws, and culture. We possess the necessary expertise and provide full support with brand registration filings, renewals, infringement evaluations, oppositions, and arbitration.
Brand Registration
Trademark registrations in our region require filing within each jurisdiction, which comes with individual requirements and laws. Galenica Health boasts of having registered dozens of products and businesses across the area due to our country-specific understanding of each market’s local requirements, laws, and culture. We possess the necessary expertise and provide full support with brand registration filings, renewals, infringement evaluations, oppositions, and arbitration.
Brand Development
Establishing a strong brand is pivotal in setting your company apart from competitors. At Galenica Health, our team of experts offers comprehensive solutions to build and position your brand effectively. From crafting brand identity and designing logos to developing impactful taglines, we provide end-to-end support to create thriving brands.
Our approach ensures that brands resonate with local culture and language, explicitly tailored to target audiences within each market. By leveraging our expertise in cultural nuances and market dynamics, we help you develop brands that are not only relevant but also resonate deeply with your target audience.
Product Launch
Launching a product in a foreign market can present numerous challenges, making it essential to have expert guidance and support. At Galenica Health, we are seasoned professionals in this field, equipped with comprehensive knowledge and experience to navigate every aspect of the business. We remain adaptable and responsive to evolving market needs, ensuring the success of your product launch.
Our comprehensive product launch solutions encompass:
Packaging: We collaborate closely with your team to oversee the packaging process, ensuring that labels carry the correct importation codes or barcodes and meet local regulatory requirements seamlessly.
Importation: Our dedicated team provides complete assistance during the importation process, arranging product-specific transportation services, including cold-chain transport, and ensuring compliance with manufacturer requirements. We receive your consignment and manage customs clearance at the destination efficiently.
Storage: We offer warehouse facilities with cold-chain spaces to accommodate your specific storage needs. Our warehouses undergo rigorous checks and inspections to guarantee your goods' safe and proper storage until distribution.
Distribution Channels: Leveraging our extensive network of first-class distributors and wholesalers, we facilitate fair pricing and efficient distribution channels to ensure broad market access for your products. With Galenica Health as your partner, you can trust to have a seamless product launch, allowing you to focus on achieving success in your target market.
Product Launch
Launching a product in a foreign market can present numerous challenges, making it essential to have expert guidance and support. At Galenica Health, we are seasoned professionals in this field, equipped with comprehensive knowledge and experience to navigate every aspect of the business. We remain adaptable and responsive to evolving market needs, ensuring the success of your product launch.
Our comprehensive product launch solutions encompass:
Packaging: We collaborate closely with your team to oversee the packaging process, ensuring that labels carry the correct importation codes or barcodes and meet local regulatory requirements seamlessly.
Importation: Our dedicated team provides complete assistance during the importation process, arranging product-specific transportation services, including cold-chain transport, and ensuring compliance with manufacturer requirements. We receive your consignment and manage customs clearance at the destination efficiently.
Storage: We offer warehouse facilities with cold-chain spaces to accommodate your specific storage needs. Our warehouses undergo rigorous checks and inspections to guarantee your goods' safe and proper storage until distribution.
Distribution Channels: Leveraging our extensive network of first-class distributors and wholesalers, we facilitate fair pricing and efficient distribution channels to ensure broad market access for your products. With Galenica Health as your partner, you can trust to have a seamless product launch, allowing you to focus on achieving success in your target market.
Tender Participation
Are you seeking to become a government-listed supplier in the Latin American region? Galenica can open doors to lucrative opportunities in this rapidly expanding market segment. With our qualifications and expertise, we are well-equipped to assist you in participating and winning government tenders.
Our comprehensive tender participation services include:
Understanding Procurement Laws: We know public procurement laws and policies at national and local levels, ensuring compliance and maximizing your chances of success.
Expert Guidance: Our experienced team conducts thorough research and provides valuable advice on all aspects of the bidding process, ensuring you are well-prepared and informed.
Proposal Development: We work closely with you to craft a compelling and competitive proposal for your tender application, effectively highlighting your strengths and capabilities.
Risk Identification: Leveraging our extensive database and expertise, we identify and analyze potential red flags, helping you mitigate risks and avoid critical oversights during the bidding period.
With Galenica Health by your side, you can confidently navigate the complexities of government tendering processes and secure lucrative contracts in markets in our region.
