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

Address:

WT Morumbi 

Av. das Nações Unidas, 14261 - Block A

São Paulo / SP

BRAZIL

Phone:

(+55 11) 99420-1726 / (+55 11) 99483-0623

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