SMOLT LIFE SCIENCES

Facebook Twitter Youtube Linkedin
Menu

Regulatory Services

At SMOLT Lifesciences, we provide comprehensive regulatory support to ensure seamless clinical trial approvals, ethical compliance, and adherence to global regulatory standards. Our expertise in regulatory strategy, ethics committee submissions, training, and quality assurance helps clients navigate complex regulatory landscapes efficiently.

 

We assist in obtaining ethical and regulatory approvals through structured, compliant processes. Our services include:

  • SOP Preparation to align with global regulatory guidelines
  • Registration support for IEC, DHR, and DCGI approvals
  • SUGAM & NAITIK Portal Registration to streamline regulatory submissions
  • Training programs for IEC members to ensure ethical compliance
  • Ethical Review Board (ERB) and Regulatory Authority submissions for trial approvals

          Our expertise ensures that all regulatory and ethical requirements are met, minimizing delays and ensuring study integrity.

 

 

We provide tailored regulatory strategies to optimize clinical development and accelerate approvals. Our services include:

  • Regulatory pathway analysis for new drug and device approvals
  • Risk assessment and mitigation strategies
  • Engagement with global regulatory agencies to streamline approvals
  • Regulatory dossier preparation and submission

 

 

We offer customized training programs to ensure compliance with evolving regulatory requirements:

  • GCP, GMP, and regulatory guidelines training
  • Training for sponsors, investigators, and study teams
  • Workshops on ethical and regulatory updates

 

 

Our audit and inspection services help clients maintain compliance and readiness for regulatory reviews:

  • Pre-audit compliance assessments
  • Regulatory inspection readiness training
  • Mock audits and gap analysis
  • CAPA (Corrective and Preventive Action) implementation

 

 

We provide real-time regulatory insights to help clients stay ahead of industry changes:

  • Monitoring global regulatory updates
  • Impact assessments of regulatory changes on ongoing trials
  • Competitor regulatory strategy analysis

 

 

Our secure documentation archiving ensures proper record-keeping for regulatory submissions, inspections, and audits. We also implement quality control measures to ensure all regulatory documents meet compliance standards.

 

Why Choose SMOLT for Regulatory Services?

  • Regulatory Expertise: Experienced professionals with in-depth knowledge of global regulatory frameworks.
  • Comprehensive Support: End-to-end assistance, from ethics committee approvals to audits and training.
  • Proactive Compliance: Continuous monitoring of regulatory changes to keep studies aligned with requirements.
  • Efficient Approvals: Strategic regulatory planning to accelerate market entry and minimize delays.

At SMOLT Lifesciences, we ensure regulatory excellence, compliance, and efficiency in clinical research. Partner with us for seamless regulatory solutions that drive successful study approvals and market access.