Regulatory Consulting Services
Whether you're developing pharmaceuticals, medical devices, or biologics, ensuring compliance with regulatory standards is essential to bringing your products to market. However, the complexities of regulatory pathways, submission processes, and post-market requirements can be overwhelming and pose significant risks if not managed correctly.
At Viltis Consulting, we specialize in providing expert regulatory consulting services that help you overcome these challenges. Our team of seasoned professionals offers strategic guidance and hands-on support in all aspects of regulatory affairs, compliance audits, quality systems, and more. By partnering with us, you can confidently navigate the regulatory environment, reduce risks, and ensure your products meet all necessary standards for approval.
Pharmaceuticals
Viltis provides you with support in regulatory, clinical research, and quality to bring safe and effective drugs to market.
Regulatory Affairs
- Regulatory Strategist: Develops tailored strategies to navigate complex regulatory pathways, ensuring timely approvals.
- Regulatory Submission Specialist: Expertly prepares and submits regulatory documents to secure necessary approvals.
- Regulatory Compliance Auditor: Conducts thorough audits to ensure adherence to all regulatory standards.
- Regulatory Liaison: Acts as a bridge between your company and regulatory bodies, facilitating smooth communication and compliance.
- Clinical Regulatory Affairs Specialist: Ensures that clinical trials are fully compliant with regulatory requirements, from trial design through execution.
- Regulatory Quality Manager: Manages and integrates quality systems to ensure ongoing regulatory compliance.
- Data Integrity Compliance Specialist: Ensures that electronic records and signatures comply with 21 CFR Part 11, safeguarding data integrity.
Clinical Research
- Clinical Regulatory Affairs Specialist: Ensures clinical trials comply with regulatory requirements.
Quality Systems
- Regulatory Quality Manager: Manages quality systems to ensure regulatory compliance.
- Data Integrity Compliance Specialist: Ensures electronic records and signatures are compliant with 21 CFR Part 11.
Medical Devices
Our regulatory affairs experts guide you through the submission process and ensure that your devices meet all necessary standards.
Regulatory Affairs
- Regulatory Affairs Manager: Oversees regulatory submissions and ensures effective interactions with regulatory agencies.
- FDA Submission Specialist: Prepares and manages submissions to the FDA, ensuring timely approvals.
- International Submission Specialist: Handles regulatory submissions to international bodies, ensuring global compliance.
- Regulatory Compliance Specialist: Ensures ongoing compliance with evolving regulatory requirements, mitigating risks.
- Post-Market Regulatory Compliance Specialist: Monitors and ensures compliance with post-market regulatory requirements, safeguarding your product's market presence.
- Audit Readiness Specialist: Prepares for and manages regulatory audits to ensure your company is always audit-ready.
Quality Systems
- Regulatory Quality Engineer: Integrates quality systems with regulatory requirements.
- Regulatory Documentation Specialist: Manages and updates regulatory documentation.
Post-Market Surveillance
- Post-Market Regulatory Compliance Specialist: Ensures compliance with post-market regulatory requirements.
- Audit Readiness Specialist: Prepares for and manages regulatory audits.
Biologics
Viltis is adept at understanding the challenges biologics development offers and we offer our services to ensure that your biologic products meet all necessary standards.
- Regulatory Pathway Strategist: Develops strategies tailored to the regulatory landscape for biologics, ensuring a smooth path to approval.
- Regulatory Submission Specialist: Expertly prepares and submits regulatory documents specific to biological products.
- Regulatory Compliance Trainer: Provides targeted training on regulatory compliance requirements, ensuring your team is always informed.
- Gap Analysis Specialist: Identifies and remediates compliance gaps, ensuring your product meets all regulatory standards.
- Clinical Regulatory Affairs Specialist: Ensures that clinical trials for biologics meet all regulatory standards, from protocol development to trial execution.
- Biologics Regulatory Quality Manager: Oversees quality management systems to ensure they meet stringent regulatory requirements for biologics.
- Data Integrity Specialist: Ensures the integrity of data in compliance with regulatory standards, particularly for biological products.
Most Popular Regulatory Job Positions
Pharmaceuticals
- Regulatory Submission Specialist
- Regulatory Compliance Auditor
- Regulatory Strategist
Medical Devices
- Regulatory Affairs Manager
- FDA Submission Specialist
- Regulatory Compliance Specialist
Biologics
- Regulatory Pathway Strategist
- Regulatory Submission Specialist
- Regulatory Compliance Trainer