Regulatory Support

Regulatory Compliance & Quality Assurance (QA) Services

Ensuring Excellence at Every Stage of Small Molecule Drug Substance Development

Regulatory Compliance ensures that the development and manufacturing processes meet specific quality, safety, and efficacy requirements. At Aragen, we provide expert Regulatory Compliance & Quality Assurance (QA) Services to support small molecule drug substance development through every phase—from early research and clinical trials to commercial manufacturing. Our goal is to help you navigate complex regulatory environments while ensuring that your drug product meets the highest standards of quality, safety, and efficacy.

Quality Assurance (QA) ensures that all aspects of the drug development lifecycle, including manufacturing, testing, and documentation, meet predefined standards and regulatory requirements. QA processes ensure product consistency, safety, and compliance throughout the development process. Our Regulatory Compliance & QA services help you meet these stringent requirements, ensuring smooth transitions between phases and successful regulatory submissions.

Our Services

We offer comprehensive support across the entire drug development lifecycle, from preclinical studies to commercial product launch, ensuring compliance at every step.

Early Phase

In the early phases of drug development, regulatory compliance and quality assurance activities focus on setting the foundation for compliance in subsequent phases. We help you prepare for clinical trials, ensuring the product development process meets regulatory standards and is scientifically sound.

• Regulatory Strategy Development: We help define a regulatory strategy to guide your drug substance development, ensuring that early-stage activities align with future regulatory submissions.
• Preclinical Regulatory Compliance: Ensuring compliance with preclinical regulations, including GLP (Good Laboratory Practice) guidelines for non-clinical safety studies.
• IND (Investigational New Drug) Application Support: Assistance in preparing and submitting an IND application to the FDA or other regulatory bodies, ensuring that all required preclinical data, manufacturing information, and clinical plans are in place.

Quality Assurance in Early-Stage Development

Implementation of QA processes to support the development of early phase manufacturing processes, including documentation, batch records, and quality control systems.

• Risk Management: Identifying potential regulatory or compliance risks early and implementing mitigation strategies to prevent delays in the clinical trial process.

During the late phase of development, the focus shifts to meeting regulatory expectations for larger-scale clinical trials and the eventual submission of a New Drug Application (NDA) or Biologics License Application (BLA). Our services help ensure that all necessary data, documentation, and compliance systems are in place for successful regulatory review.

• Regulatory Submissions & Filing Support: Preparation and submission of essential regulatory documents for Phase II and Phase III trials, including the submission of Investigational Product Dossiers and Clinical Trial Authorizations (CTAs).
• GMP (Good Manufacturing Practice) Compliance: Ensuring that manufacturing processes for clinical batches are compliant with GMP standards, including proper validation, documentation, and testing procedures.
• Audit Preparation & Management: We help you prepare for regulatory agency inspections, including mock audits, gap analysis, and audit readiness support to ensure compliance with GMP, GLP, and GCP (Good Clinical Practice).
• Quality Management Systems (QMS): Developing and implementing robust QMS to ensure that all processes from manufacturing to testing are controlled, documented, and compliant with international standards.
• Clinical Trial Compliance: Ensuring that clinical trials are conducted in compliance with GCP and ICH E6 guidelines, providing support for trial monitoring and data integrity.

In the commercial phase, maintaining regulatory compliance is critical to ensure ongoing product quality and market acceptance. Our services support the transition from clinical trials to full-scale commercial production, including ongoing compliance with GMP, regulatory filings, and post-market surveillance.

• Regulatory Filings for Market Approval: Support in preparing and submitting the New Drug Application (NDA), Marketing Authorization Application (MAA), or other market approval documents for regulatory agencies.
• Commercial-Scale GMP Compliance: Ensuring that your commercial manufacturing operations meet stringent GMP requirements, including batch record reviews, material traceability, and production lot release.
• Post-Approval Changes & Compliance: Managing regulatory changes to manufacturing processes, raw materials, or formulations post-approval, ensuring compliance with regulatory guidelines for post-market modifications.
• Post-Marketing Surveillance (PMS): Implementing robust post-market surveillance programs to track product performance, monitor adverse events, and ensure ongoing regulatory compliance after-market launch.
• Continual Quality Assurance: Ongoing QA activities, including the review of manufacturing processes, regulatory filings, and audits, to ensure continuous adherence to quality standards and regulatory requirements.