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Contact : (321) 445-1969

Regulatory Compliance

Excellent expertise in global drug and devices development leads us to provide a variety of services in the regulatory area:

Global Regulatory Strategies and implementations.
Regulatory support of clinical development and operations, marketing, and medical Affairs.
Filings and advocacy.
Labeling and Representations.
Life cycle of documentation management.
Filing, Certificates, Approval, and beyond.
Turnkey pre and post-marketing regulatory representation of advocacy.

Regulatory Maintenance of Marketed Products

Life Cycle Management of Recently Marketed Products.
Labeling, Updates, and Harmonization.
Regulatory venues of Product and/or Technology Transfers.
Coordination of Regulatory Certificates.
Training of personnel in pharmaceutical companies and regulatory agencies from the emerging markets.