Apurun - Regulatory and Compliance Support
Regulatory and Compliance Support

Complete Regulatory and Compliance Support

At Apurun, we offer comprehensive regulatory and compliance support to ensure that your pharmaceutical products meet the highest standards and regulatory requirements. Our team of experts is dedicated to guiding you through the complex landscape of regulatory compliance, from initial development to commercial production.

Documentation

We provide meticulous preparation and management of all necessary regulatory documents to facilitate smooth submissions and approvals. Our services include:

  • Regulatory Dossier Preparation: Comprehensive assembly of regulatory dossiers for submissions.
  • Technical Writing: Expert technical writing for scientific and regulatory documents.
  • Submission Management: Handling electronic and paper submissions to regulatory bodies.
  • Document Review: Thorough review of all documents to ensure accuracy and compliance.

GMP Compliance

Ensuring Good Manufacturing Practice (GMP) compliance is critical for product quality and regulatory approval. We provide support in:

  • GMP Audits: Conducting internal and external audits to ensure compliance with GMP standards.
  • GMP Training: Providing training programs on GMP principles and best practices.
  • Quality Systems: Developing and implementing robust quality management systems.
  • Regulatory Guidance: Offering guidance on GMP requirements and compliance strategies.

IND and NDA Submissions

Our team has extensive experience in preparing Investigational New Drug (IND) and New Drug Application (NDA) submissions. We ensure that your submissions are complete, accurate, and compliant with regulatory standards. Our services include:

  • IND Preparation: Comprehensive preparation and compilation of IND submissions.
  • NDA Submission: Expert assistance in preparing NDA submissions for regulatory approval.
  • Regulatory Strategy: Developing effective regulatory strategies to streamline the approval process.
  • Agency Liaison: Acting as a liaison with regulatory agencies to address any questions or concerns.

Preclinical and Clinical Support

We provide support throughout the preclinical and clinical development stages, ensuring that your studies meet regulatory requirements and scientific standards. Our services include:

  • Study Design: Assisting in the design of preclinical and clinical studies.
  • Protocol Development: Developing detailed protocols for preclinical and clinical trials.
  • Regulatory Submissions: Preparing and submitting preclinical and clinical data to regulatory agencies.
  • Compliance Monitoring: Monitoring studies to ensure compliance with regulatory and ethical standards.

Technology Transfer

Our technology transfer services ensure a seamless transition from development to manufacturing, minimizing risks and ensuring consistency. Our services include:

  • Process Transfer: Facilitating the transfer of manufacturing processes to production facilities.
  • Method Transfer: Transferring analytical methods from development to manufacturing.
  • Training and Support: Providing training and ongoing support during the technology transfer process.
  • Validation: Ensuring that transferred processes and methods are validated and compliant.