Mind the Gap
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.
Local regulatory requirements.
Meetings with Anvisa.
Support for technical and clinical protocols.
Qualification of suppliers.
GMP mock-up Inspections.
Support during Anvisa
certification processes for
APIs, drug products and biological products.
New products, markets and partners. Regulatory step by step for start-up and new business units.
Clippings and Alerts with everything that is most relevant in regulatory affairs for you.
Custom market mapping.
We connect companies.
Acquisition of shelf-companies.