REGULATORY STRATEGY
DUE
DILIGENCE
Compliance assessment and regulatory risk mapping in the acquisition, licensing, sale, transference of M.A. ownership, clones, marketing authorization approval and post-approval variation processes.
SCIENTIFIC ADVISORY
Local regulatory requirements.
Meetings with Anvisa.
Support for technical and clinical protocols.
AUDITS AND INSPECTIONS
Regulatory audit.
Qualification of suppliers.
GMP mock-up Inspections.
Support during Anvisa
certification processes for
APIs, drug products and biological products.
ROAD-MAPs
New products, markets and partners. Regulatory step by step for start-up and new business units.
REGULATORY INTELLIGENCE
Clippings and Alerts with everything that is most relevant in regulatory affairs for you.
Custom market mapping.
Strategic assessments.
HOSTING AND PARTNERSHIPS
We connect companies.
Acquisition of shelf-companies.
License hosting.
Outsourcing.
“However beautiful the strategy, you should occasionally look at the results.”
Winston Churchill