Regulatory solutions for the health industry
MCFarma Spa provides specialized advisory and consulting services in pharmaceutical, cosmetic, food and medical technology. We help your company meet the most demanding regulatory standards in Chile and Latin America.
Areas of expertise
Expertise in public health, private sector and academia
MCFarma Spa is a specialized consulting firm born from the convergence of experience in public and private health, university teaching and sustained professional practice in the pharmaceutical and cosmetic regulatory sector.
Our methodology starts by understanding the complexity of each organization: its processes, gaps and goals. From there we design regulatory and quality strategies that are practical, efficient and sustainable over time.
Our team of consultants and specialists joins each project according to the client's needs, guaranteeing a wide range of highly specialized and personalized solutions.
Specialized consulting and advisory
We offer comprehensive solutions covering the entire regulatory and quality cycle, from initial strategy to operational implementation.
Regulatory Affairs
Advisory on regulations for pharmaceutical, cosmetic, medical supply and food supplement products before the ISP and other authorities.
Product Registration
Evaluation and documentary preparation for registration before health authorities in Chile and Latin America. Medicines, cosmetics and medical devices.
Regulatory Strategy
Definition of registration routes, action plans and strategies for launching new products to market with minimum risk and maximum efficiency.
Product Importation
Advisory on all requirements for the legal importation of pharmaceuticals, supplements, cosmetics and medical devices into the country.
GMP / GLP / GDP Audits
Internal and supplier audits on quality systems under GMP, GLP, GSP and GDP standards. Diagnosis, gaps and improvement plan.
Good Practices GDP&T
Regulatory implementation of good storage, transport and distribution practices. Cold chain and packaging qualification.
Equipment Qualification
Qualification of pharmaceutical production equipment, cold equipment and conditioning areas under validated quality principles.
Health Authorizations
Management of health authorizations for health establishments, implementation of quality systems and HACCP principles.
Specialists committed to your project
Marta Castillo Trincado
Pharmaceutical Chemist from Pontificia Universidad Católica de Chile. With a distinguished career as Technical Director in pharmaceutical production laboratories and drugstores. At CENABAST she served as Technical Director and was responsible for ministerial food programs (PNAC and PACAM) and the National Immunization Program (PNI — Vaccines). Her deep knowledge of the Chilean health system, both public and private, is the founding pillar of MCFarma Spa.
Pharmaceutical Chemists
Specialists in pharmaceutical, cosmetic and medical device regulation, with experience in ISP registrations and quality audits.
Regulatory Lawyers
Experts in health regulations, commercial contracts and legal management of authorizations before Chilean and Latin American regulatory authorities.
Ready to advance your regulatory strategy?
Let's discuss your company's challenges. No commitment, with all our expertise.
Let's talk about your project
Our team is available to schedule a meeting and learn in detail how we can support your company's goals.
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