REGULATORY STRATEGY

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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.

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SCIENTIFIC ADVISORY

Local regulatory requirements.

Meetings with Anvisa.

Support for technical and clinical protocols.

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AUDITS AND INSPECTIONS

Regulatory audit.

Qualification of suppliers.

GMP mock-up Inspections.

Support during Anvisa 

certification processes for

APIs, drug products and biological products.

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ROAD-MAPs

New products, markets and partners. Regulatory step by step for start-up and new business units.

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REGULATORY INTELLIGENCE

Clippings and Alerts with everything that is most relevant in regulatory affairs for you.

Custom market mapping.

Strategic assessments.

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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