Global Regulatory Affairs

You can rely on our practical knowledge in the North American and International regulatory arenas through all phases of the drug-development process. We offer extensive industry experience shaping project plans to meet diverse regulatory requirements. Our experts strategize the most efficient route for your product, from bioanalytical study requirements, pre-IND/pre-NDA meetings with the FDA, and applications to Competent Authorities and Ethics Committees, to successful marketing applications, while providing the necessary guidance to ensure continual regulatory compliance.

We remain current with regional regulatory requirements as they evolve. Our proactive approach and careful counseling ensure that there are no surprises. You will appreciate our streamlined communications that keep all stakeholders fully informed and engaged. Let us put our experience to work for you documenting pharmaceutical quality/chemistry, manufacturing, and controls; obtaining scientific advice and protocol assistance from the European Medicines Agency (EMA); following the FDA’s Physician Labeling Rule; adhering to scientific guidelines issued by the EMA’s Committee for Medicinal Products for Human Use; and implementing countless other regulatory requirements.

Worldwide Clinical Trials Regulatory Services offer:

• Insight on local regulatory environments
• Smooth transitions from exploratory to confirmatory stages of investigational drugs
• Expedited submissions for possible acceleration of the developmental process
• Facilitated approval of applications to conduct clinical trials of new drugs
• Responses to regulatory body requests for information
• Support for and participation in meetings with regulatory bodies

With offices and employees across the globe, we provide crucial links to major regulatory authorities and are skilled in the preparation, coordination, and management of complex multinational submissions and meetings.