Pharmaceutical Innovation LATAM
Pharmaceutical licensing driving growth in Latin America
Inspiring innovation and empowering expansion, we connect the world’s most innovative manufacturers with strategic partners across the region, backed by 17 years of professional experience.
Who We Are
Leadership in Pharmaceutical
Licensing in Latin America
We are a leading pharmaceutical licensing consulting firm specializing in connecting global innovations with the Latin American market while strengthening the distribution capabilities of local companies by diversifying their portfolios through strategic agreements that benefit both parties
- With more than 17 years of experience
- Comprehensive regulatory management
- Specialists in the Asian and European markets
- Without language barriers
Added Value
Connecting Innovation and Opportunity
At Inphoria, we transform pharmaceutical licensing opportunities into successful strategic partnerships. Our experience and unique approach allow us to serve as a bridge between global innovation and Latin America’s growth potential, eliminating time zone and language barriers.
Our commitment to transparency, trust, and the creation of long-term relationships that drive tangible results is what truly sets us apart.
SERVICES
Our Services
At Inphoria, we provide tailored solutions and guide both manufacturers and distributors toward successful agreements in fields such as oncology, diabetes, men’s health, orphan diseases, supplements, generics, and more.
Distributors and Laboratories
We act as strategic partners without generating direct costs, supporting our clients’ growth through:
- IN-Licensing Expertise: Access to innovative and high-technology products such as oncology treatments and potent & complex generics.
- Regulatory support: Technical review of dossiers to accelerate the approval process before regulatory registrations.
- Contractual and Linguistic Advisory: Consulting support for negotiation and contract drafting, eliminating language barriers
- Market Expansion Support: Market entry and commercialization strategies designed to ensure regional success.
Global Manufacturers
We facilitate your establishment in Latin America through:
- OUT-Licensing Facilitation: Connection with strategic partners in Latin America that have regulatory capabilities and strong distribution networks.
- Cultural and Language Bridge: We overcome cultural and language barriers thanks to our founder’s professional experience in China.
- Partnership Development: Selection of the right partners through a thorough vetting process to ensure strong and long-lasting collaborations.
TESTIMONIAL
Frequently Asked Questions
Is FDA approval useful when entering Colombia, or does the INVIMA process start from scratch?
As experts in INVIMA regulations, our analysis is clear: FDA approval does not provide automatic homologation nor exempt companies from regulatory procedures with INVIMA. However, it is highly valuable and can help streamline or simplify certain parts of the process.
What types of agreements are most commonly used in LATAM (dossier, supply, tech transfer, distribution)?
It depends on the commercial strategy: dossier licensing, licensing and supply agreements , technology transfer, or exclusive/non-exclusive distribution agreements.
Why are eCTD and CTD important?
The Electronic Common Technical Document (eCTD) allows the electronic submission of the Common Technical Document (CTD) from applicants to regulatory authorities such as the FDA or the EMA.
Therefore, if you are applying for the registration of a pharmaceutical, biological, medical device, or veterinary product, the eCTD format will be mandatory for regulatory submissions.
What is a CPP/CLV and in which countries is it required for registration or importation?
A Certificate of Pharmaceutical Product (CPP) or Certificate of Free Sale (CLV) is evidence that a product is authorized or marketed in its country of origin. Many countries require it depending on the registration modality.
These documents are important for the importation and commercialization of products in international trade.
When does bioequivalence (BE) apply and how does it impact licensing costs?
If the market requires bioequivalence for a specific product, the dossier fee usually increases, and the implementation timeline depends on the availability of a valid study.
Bioequivalence is used to indirectly determine whether a generic drug is safe and effective by comparing it to a reference product that has undergone clinical trials. This is especially relevant for biotherapeutic drugs, where interchangeability between products can be challenging.
Bioequivalence not only guarantees clinical interchangeability between generic medicines and their reference products but also represents a strategic tool for the sustainability of healthcare systems and broader access to safe and effective therapies.
