/ Where We Work
Regulatory depth in the markets you manufacture for
We operate inside the inspection timelines and authority expectations of each region—not as a generic overlay, but as consultants who have worked within those frameworks directly.
— Coverage by Region
Six markets, one compliance standard
Mexico & Central America
South America & Caribbean
Africa
NAFDAC, SAHPRA, and national GMP frameworks—on-site engagements for antivenom and hemoderivate producers preparing for regional or WHO pre-qualification.
COFEPRIS-aligned documentation, facility qualification, and staff training for manufacturers supplying domestic and export markets.
ANVISA, INVIMA, and national health authority requirements addressed for biologics and synthetic drug manufacturers across the region.
Southeast Asia
India
Arabian Peninsula
ASEAN harmonized GMP, BPOM, and national authority expectations for peptide and biologic manufacturers scaling toward export registration.
CDSCO Schedule M and WHO-GMP alignment for manufacturers addressing audit gaps ahead of export approvals or domestic inspections.
SFDA, MOH Gulf, and GCC registration requirements for manufacturers building or upgrading biologics and sterile production capacity.
Built around your inspection calendar
On-site and virtual engagements are scoped to your authority's inspection cycle—not a fixed consulting template. We map document gaps, qualify facilities, and train your team against the timeline your regulatory body sets.
We stay until your team owns the process. That means batch records written for your product type, training protocols built for your workforce, and audit responses grounded in your facility's actual data.
Tell us your region and your product type
We scope every engagement to the regulatory authority and product category you actually work with. Describe your compliance gap and we will outline what the work looks like.