WHY CHOOSE XTRATEGICAL PHARMA CONSULTING?
We have extensive consulting experience in a variety of areas, from pharmaceuticals, medicinal cannabis, medical devices, food supplements and cosmetics, which allows us to develop customized solutions to meet the specific needs of each organization and optimize our performance. In each project, we do our best to add value, in the sense of not being just a service provider, but your partner of choice, enabling you to anticipate and overcome challenges for a successful collaboration. We seek continuous improvement, we value communication and assertiveness, in building trustful relationships oriented towards common goals of our collaborative journey.
ABOUT US
Driven by a passion for science-based knowledge, we provide excellent strategic solutions in several areas such as in Regulatory Affairs, Market Access, Quality Management System / Site Master File and Audits, Medical Affairs, Compliance & Transparency, and Tailored Trainings and Health Literacy. Our services meet regulatory compliance standards to best address your needs, mitigating risks to achieve a successful outcome.
MISSION
Provide reliable scientific solutions that contribute to the success of organizations, driving added value in the informed health decision-making process.
VISION
To be the strategic partner of reference for the excellence of services provided in pharmaceutical consultancy, with recognition of the contribution to the success of organizations in the health and medicine areas.
VALUES
Integrity, Commitment, Loyalty, Flexibility, Ethics, Collaboration, Responsibility, Inclusion, Mutual Respect, Quality, Innovation, Sustainability.
ServiCES
REGULATORY AFFAIRS
Regulatory strategy and requirements, feasibility and planning of achievable goals,regulatory intelligence, submissions to authorities, technical translations, opinions and specialized reports.
MARKET ACCESS
Strategy and management of price requests, reimbursement and prior hospital assessment, EAP, PICO matrix and value dossier, systematic literature review and NMA, contract negotiation, price review and change.
Sistema de Gestão da Qualidade e Procedimentos
Implementação e suporte na manutenção de Sistemas de Gestão da Qualidade, Direção Técnica e Boas Práticas (BPX), agilização de processos, redação de procedimentos e formulários.
AUDITS AND CAPA PLAN
Verificação do cumprimento dos requisitos de conformidade processual, normativa e legal para mitigação de riscos e melhoria contínua.
Assuntos Médicos, Compliance e Transparência
Colaboração no desenho da estratégia pré e pós-lançamento, revisão de materiais científicos e promocionais em cumprimento dos requisitos legais, técnicos e deontológicos.
Formações Personalizadas e Literacia em Saúde
Person Responsible for Regulatory Compliance (PRRC)
Mandatário para Dispositivos Médicos (EC-REP)
Direção Técnica Farmacêutica / Responsabilidade Técnica
Farmacovigilância (EU-QPPV, Deputy QPPV, QPPV Medical Advisor, LCPPV/LSO)
Avaliador de Segurança de Produtos Cosméticos
Gestor da Qualidade
Responsável HACCP
REGULATORY AFFAIRS
Regulatory strategy and requirements, feasibility and planning of achievable goals,regulatory intelligence, submissions to authorities, technical translations, opinions and specialized reports.
MARKET ACCESS
Strategy and management of price requests, reimbursement and prior hospital assessment, EAP, PICO matrix and value dossier, systematic literature review and NMA, contract negotiation, price review and change.
QUALITY MANAGEMENT SYSTEM
Implementation and support in the maintenance of Quality Management Systems, Technical Management and Good Practices (BPX), streamlining processes, writing procedures and forms.
AUDITS AND CAPA PLAN
Verification of compliance with procedural, regulatory and legal compliance requirements for risk mitigation and continuous improvement.
MEDICAL AFFAIRS AND COMPLIANCE pharmacovigilance
Collaboration in the design of the pre- and post-launch strategy, pharmacovigilance, review of scientific and promotional materials in compliance with legal, technical and ethical requirements.
PERSONALIZED TRAINING AND LITERACY
Specialized training tailored to needs, valuing the development of human potential, with a focus on differentiation through the sharing of knowledge with a practical component.
HIGHLIGHTS
EUROPEAN HEALTH DATA SPACE
On April 24, 2024, the European Parliament approved the proposal for a regulation establishing the creation of the European Health Data Space. This innovative initiative aims to improve access to personal health data across the European Union, safeguarding the...
REFORM OF EUROPEAN PHARMACEUTICAL LEGISLATION
On April 10, 2024, the proposal for the reform of EU pharmaceutical legislation was approved, for a new European directive and regulation, to promote innovation, guarantee access to medicines and more affordable prices, while supporting research, namely new...
IMPLEMENTATION OF THE MEDICAL DEVICE REGULATION
On April 5, 2024, Decree-Law no. 29/2024, with effect from July 4, 2024, defining the provisions applicable to economic operators, healthcare institutions that manufacture and use devices in their respective facilities, as well as the rules applicable to use and...