Latin America

Market Adoption

Professional Consulting Expertise to accelerate market introduction through the following services;

  • Regulatory expertise
  • Market assessment
  • KOL recruitment & engagement
  • Patient Association engagement
  • Public and Private payer lobbying
  • Product distribution and marketing

Strategic Regulatory Services
Latin America

We have the professional capabilities and therapeutic are expertise to support your firm in the development of regulatory, clinical, and business strategies needed to
expand or start up your business operations in Latin America.

Strategic regulatory capabilities

Regulatory Assessments – Gap Analysis: country/region specific
Dossier preparation, Regulatory guidance & Support.
DMF, CMC, CTD compilation support, review & filing.
Regulatory Hosting-Agent Services /Country/Region

Post – Marketing Core Capabilities

Product Lifecycle management.
Pharmacovigilance: SOP development & gap analysis.
Auditing of Pharmacovigilance systems to assess compliance with European, Canadian and US- LATAM legislation.
Pharmacovigilance training.
Publishing support.
Training Expertise: QA/QC, GMPs, GCPs, whether drugs or devices, other. Bilingual capabilities (English/Spanish/Portuguese) as required by client.

Clinical trial support

Services

Preparation and submission of CTAs/amendments (substantial, non-substantial) and notifications.
Submissions to both Regulatory Agency and Ethics Committee.
Investigator meetings
Clinical study site: budget preparation, review and negotiation/country specific.
Detection, engagement for: “hosting services” for drug importation and storage.

Capabilities

Trusted network of Key Opinion leaders: pediatric & adult per country/ across LATAM region.
Access to state-of-the -art facilities and clinical laboratories in Mexico, Colombia, Argentina and Brazil.
In-house expertise for clinical study monitoring & site training (English/Spanish/Portuguese)

Other Key Strategic Support Services

Market Access

Market Assessment & Reimbursement Guidance
Creation and implementation of growth strategies
Marketing and sales strategies/Distribution network
Management of Regional Alliance Partners
Out licensing partner management
Hosting/Agent/Representation agreements; licenses, permits, corporate-plant manufacturing registration support, other
Real-world evidence (RWE) 
National Formulary submission/inclusion (Mexico, Brazil, Colombia, Argentina)

Latest Articles

WESSX pro-active participation as session leader (2014-2020). Regulatory Affairs Professional Society (RAPS) “Regulatory Convergence Congresses” Latin American Regulators Forum. Other regulatory/medical global and regional congresses and webinars.

Working together

Contact Silvia Bendiner

Executive Partner

+1(407)607-4868 (USA)
+39 3331415067 (ITALY)
sbendiner@wessx.com

WESSX Footprint

Argentina, Australia, Brazil, Canada, Chile, The Netherlands Colombia, Mexico, United Kingdom, United States, Puerto Rico.

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