The Olsen Group provides a variety of legal and counseling services
to clients in industries regulated by the United States Food and Drug
Administration (FDA) and the European Union Medical Device
Directive.
Licensing Submissions
Drafting or reviewing all documents required to obtain approval of new drugs
or devices in the United States, the EU and Canada, as well as providing
legal strategy for approval and clearance pathways for PMAs, BLAs, NDAs,
ANDAs, INDs, IDEs, and 510(k)s;
Regulatory Guidance
The Olsen Group provides a "reality check" to clients with respect to their
interpretation of regulatory issues in today's environment. Issues such as
potential recalls, deviation reporting, changes to be reported,
non-conforming materials, out of specification test results, exports, labeling
and promotion, and GMP requirements, are among the broad universe of
topics about which clients obtain guidance.
GMP and ISO 13485:2003 Audits
The Olsen Group provides a broad range of audits of good manufacturing
practices and ISO 13485:2003 compliance, including Active Pharmaceutical
Ingredients (API), Biotech, Scale-up and Post Approval Changes (SUPAC),
preparation for Pre-Approval inspections (PAI), Good Tissue Banking
Practices, etc. Prompt, detailed audit reports with findings and practical
recommendations are our specialty. The Olsen Group also provides QA
audits of the adequacy of the QA program and quality manual, including the
organizational structure, composition, functioning, and monitoring of the
program, or its components.
Corrective Action Plans
Prompt, comprehensive corrective actions to FDA's compliance
communications, such as Warning Letters, Notices of Intent to Revoke,
Clinical Investigator Disqualification, etc., are essential to your firm's survival.
The Olsen Group provides an assessment of the key themes and underlying
issues and develops a comprehensive plan to address them. The Olsen
Group also provides a plan for effective communication with FDA or other
appropriate regulatory agencies.
Compliance Analyses
The Olsen Group analyzes your compliance position against FDA and EU
regulatory requirements and policies. The Olsen Group can provide insight
into FDA's likely views of a clients regulatory position, including the bases
for FDA enforcement actions and appropriate approaches to prevent and/or
cope with the actions. Typical sources of enforcement action reviews
include: Internal Audit Results, 483's, Complaints, Adverse Experience
Reports, Deviation Reports, etc.
Clinical Trials
The Olsen Group can assist in the design, conduct and authorization of
clinical trials to support FDA product approvals and clearances.
Privileged and Confidential
Because the Olsen Group is a Law firm offering compliance counseling, our
work is privileged and confidential. This includes audits and reviews of
critical and sensitive operations including CAPA system audits, design
review audits and clinical data audits.
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