Latin American Market Access
The direct link to take your project to the next level.
About Latin American Market Access
We are a company passionate about technological innovation and its impact on the health system.
We are in a world of constant change and prepared to be part of it. Biotechnology, genetic engineering, information technology, Artificial Intelligence have come to stay.
Made up of an interdisciplinary team, day to day we cooperate to bring the best of health technology to Latin America, providing strategic support to manufacturers, importers and distributors of medical devices, IVDs, drugs for rare and complex diseases and high-cost treatments.
We are connecting the main participants in the distribution and access of medical products and new therapies to the Latin American market
Our Core insight
Experience in global networking
Partnership building
Excellent strategic planning skills
Experience in managing multi - stakeholders
Our Holistic proposal to support your business
Services
There is a gap between the health industry and health entities. Companies need to adapt and create smart regulatory strategies, we design them. It is a challenging path that translates into a competitive opportunity, which is why we have specialized in a wide range of services that we make available to you.
End to end regulatory services
Regulatory Intelligence
- Regulatory environment and Outlook
- Current regulatory life cycle requirements outline
- Healthcare System Key developments and trends
- Pharmaceutical Business ecosystem and trends
Strategy and Consulting
- High level Regulatory & Supply Chain Strategy (Submission planning)
- Regulatory Project Plan (from ideation to product launch)
- Regulatory Risk mapping and mitigation plan.
RA & QA Activities
- QMS
- Health accreditation
- Health registrations (product life cycle)
- CTD Gap assessment against local requirements and mitigations plans to bridge the gaps.
- Dossier country specific adaptation from core dossier.
- Dossier GAP Analysis
Labeling adaptation and lifecicle managment
- Artwork Creation
Market Access and Competitive Analysis
- Product viability
- Distribution channels
- Public or private market
- Monitor regulatory and legal landscape and potential competitors.
Sanitary Surveillance
- Implementation of Surveillance System In Company
- Training
- Case Management
- Security reports
- Quality System applied to Surveillance
- Audits
- Building consensus on cross-functional, multi-agency teams.
- Strategies based on our Knowledge of public health, practices, and programmatic implementation.
Compliance
- Context and Initial Surveys
- Policy Development and Documentation
- Diagnosis and Work
- Staff Awareness and Training – Compliance Program
FREQUENTLY ASKED QUESTIONS
When should a representative or Distributor be appointed?
In the event that the manufacturer does not have its own headquarters in the target country of Latin America, it is necessary to designate a representative, with whom a contract will be signed. The representative can be a natural or legal person or a company authorized by the Ministry of Health of the country. This person or company represents the manufacturer before the Health Authority. The name and address of the representative must be declared on the product labeling.
Can any medical product be registered in LATAM?
In general, the Health Authorities of the region are aligned with the reference regulations (FDA, EMA, Canada). Products that have prior approval in a High Sanitary Surveillance country can be registered without GMP inspection of the elaborated plant (except Brazil), presenting the corresponding technical documentation, ISO 13485 Certification of the manufacturer and FSC or CFG of a high Sanitary Surveillance country.
Are legalized documents necessary?
Yes, for example: PoAs, Third-party manufacturing agreements, CPP /CMP. GMPc, Declaration letters. If both countries (issuer and recipient of the document) are members of the HCCH, the documents must be apostilled.
How to minimize delays in the dossier approval?
Preparation of the maximum complete dossier to exclude requests from the Authority. Informing the Client about possible Authority questions at the stage of preparing the dossier.
Can variations be submitted to the agency during the MAA review process?
We do not recommend this as it will likely cause delays to final approval.
Are there any specific regulations regarding drugs for rare diseases?
The regulation of drugs for rare diseases is not harmonized in the Latam region. Thus, a company may find a wider range of regulatory requirements to register a drug for rare disease. Since no general approach can be followed it is advisable to evaluate a country specific regulatory strategy.
Is it possible to apply for an Orphan drug designation?
It depends on the country because in many Latam countries there is no Orphan Drug Designation as it is granted in the EU. However, there may be government incentives to support access to drugs for rare disease.
Is there any fast-track approval for drugs for rare disease?
Although in many Latam countries there is no fast-track approval for drugs for rare disease there could be different regulatory approaches that would allow your company to shorten the review and approval process.