Regulatory Affairs /
Regulatory Compliance

Services for the Pharmaceutical (Branded and Generic), and Biological Industries

Tunnell Consulting is an expert partner in interpreting the complicated regulatory environment actively confronting the pharmaceutical and life sciences industries. From discovery state to market approval – we guide you through the ever-changing details of FDA demands for filings, submissions, analysis and communication. We decipher regulations, anticipate regulators’ questions, develop an alliance between you and the FDA, and identify potential barriers to approval before they become major regulatory roadblocks.

Tunnell Consulting’s Regulatory Experts Will Help You:

Evaluate Regulatory Activities

Review all communications and submissions from drug discovery to market approval, making certain all actions are efficient, compliant and complete to maintain a professional rapport with FDA.

Develop Regulatory Strategy

Draw from our expert knowledge and experiences to design an efficient General Investigation Plan, negotiate its acceptance, and create a robust manufacturing strategy that improves test reproducibility, produces an accurate representative supply, and helps develop successful clinical studies.

Conduct Regulatory Compliance

• Annual Product Reviews
• Compliance Assessments
• Remediation
• Annual Updates to Regulatory Filings
• PAI Readiness Audits

Prepare All Regulatory Submissions

Meet with project teams to provide leadership for the timely coordination and assembly of regulatory documentation. We explain exactly what technical information is needed, and in what format, to ensure accurate and complete submissions (IND, CTD/NDA, ANDA, IDE, PMA, BLA, and 510(k)).

Partner with Regulatory Authorities

Develop a "good business" relationship with FDA by planning the timing of submissions, contacting FDA when additional information is needed, and requesting/ facilitating critical meetings.

Provide Leadership to Project Teams

Communicate regulation changes and clarify regulation interpretations to ensure appropriate actions and responses. For example, regulatory changes might impact clinical study programs, pharm/tox study programs, or CMC development strategies in a way that requires design modification.