Presenting the innovative scientific team.
Sebastián Estrada Gómez, CEO
Pharmacist.
M.Sc. in Research - development and use of medicaments.
Ph.D. in Pharmaceutical Sciences with emphasis in Biotechnology.
Global Training Hub in Biologics member.
International Society on Toxinology member.
Full lifecycle coverage
From bench record to batch release
We cover facilities design, R&D, preclinical trials, document preparation, and staff training—on-site or virtual. Every engagement is scoped to your product type and your regulatory gap.
We don't hand over a binder and leave. We stay until your team can run the process without us.
Training
Documentation
R&D and Preclinical
On-site and virtual staff training
Batch records and document revision
New medicament design through trials
We do care about data integrity, we write, audit, and revise batch records, master files, and SOPs to meet current regulatory standards in your target markets.
From facilities layout and new product design to preclinical trial management—structured for regulatory submission from day one.
GxP training built around your facility, your SOPs, and the product lines your team actually manufactures.
GMP - GLP - GDoc - PQS
Product-specific expertise
Antivenoms are life saving solutions.
Our biologics practice covers antivenoms and human hemoderivates—products with manufacturing complexity most consultants have never touched. We also work across synthetic and peptide-based medicaments.
Facilities, documentation, and training protocols are written for your product category—not adapted from a generic GMP template.
Snakebite is considered the most lethal of the 20 neglected tropical diseases (NTDs) listed by the World Health Organization (WHO) and is considered a Low Medium Income Countries (LMIC) disease. Inadequate investment in research and development and the lack of interest of big pharma industry to attend a burden disease affecting LMIC are the main factors contributing to the low alternatives available to treat snakebite properly, opportunely, and effectively. Access to good-quality antivenom solutions are the keystone between life and death.
— GxP · Biologics · Compliance
Compliance earned on the manufacturing floor.
GXP Pharma Consultancy closes the audit gap for mid-market manufacturers in Latin America, Africa, Southeast Asia, and MENA—with hands-on work in biologics, synthetics, and peptide-based medicaments.
Where we operate
Your region. Your regulatory environment.
We engage on-site and virtually across Mexico, Central and South America, the Caribbean, Africa, Southeast Asia, India, and the Arabian Peninsula—wherever your facility needs to close a compliance gap.