Regulatory Services
Services > Regulatory Services
1. Dossier Compilation and Review: Ashab Group provides expert services in compiling and reviewing dossiers. We ensure all necessary information is included for regulatory submissions, adhering to guidelines.
2. DMF Preparation and Submission: We offer end-to-end support in preparing and submitting Drug Master Files (DMFs). Our team gathers confidential and detailed information for API manufacturing, ensuring compliance with regulations.
3. Regulatory Strategy and Compliance: Ashab Group helps develop effective regulatory strategies, staying updated with the latest guidelines. We ensure dossiers and DMFs meet regulatory expectations for successful product approvals.
4. Lifecycle Management and Maintenance: We provide ongoing support for dossier and DMF updates to reflect changes in manufacturing, formulations, or regulations. Our goal is to maintain compliance and regulatory approvals throughout the product lifecycle.
1. BE Study Design and Conduct: Ashab Group offers services in designing and conducting Bioequivalence (BE) studies. We ensure the studies are well-planned and executed according to regulatory requirements.
2. Data Analysis and Reporting: Our team provides thorough analysis of BE study data and prepares comprehensive reports. We focus on accuracy and compliance with regulatory guidelines.
3. Regulatory Compliance: Ashab Group ensures that BE studies are conducted in accordance with regulatory standards and guidelines. We assist clients in meeting the necessary regulatory requirements for successful submissions.
4. Expert Consultation: Our experienced professionals provide expert consultation throughout the BE study process. We offer guidance on study design, regulatory compliance, data interpretation, and overall strategic support.
1. Technical Document Preparation: Ashab Group offers services in preparing technical documents for regulatory submissions. We ensure the documents are comprehensive and accurate, meeting regulatory requirements.
2. Review and Quality Control: Our team conducts thorough reviews of technical documents, ensuring accuracy and adherence to regulatory guidelines. We prioritize quality control to optimize the document’s content and presentation.
3. Regulatory Compliance: Ashab Group ensures technical documents are compliant with relevant regulations and guidelines. We stay updated on regulatory changes to provide clients with the most up-to-date and compliant documentation.
4. Expert Guidance: Our experienced professionals provide expert guidance and consultation throughout the technical document preparation process. We offer insights on content, structure, and regulatory expectations to support successful submissions.
1. License and Certification Assistance: Ashab Group provides services in assisting with licenses and certifications. We support clients in obtaining the necessary permits and certifications required for their specific industry or sector.
2. Regulatory Compliance: Our team ensures that clients meet regulatory compliance standards for licenses and certifications. We stay updated with the latest regulations and guidelines to provide accurate and timely assistance.
3. Documentation and Application Preparation: We help clients prepare the required documentation and complete the application process for licenses and certifications. Our team ensures that all necessary information is included and that the applications are properly submitted.
4. Expert Consultation: Ashab Group offers expert consultation throughout the licensing and certification process. We provide guidance on regulatory requirements, documentation, and any additional steps needed for successful acquisition of licenses and certifications.
1. FSSAI Compliance Assistance: Ashab Group provides services to ensure compliance with the Food Safety and Standards Authority of India (FSSAI) regulations. We assist clients in meeting the necessary requirements and guidelines set by FSSAI.
2. Registration and Licensing Support: Our team helps clients with the registration and licensing process with FSSAI. We guide them through the application process and ensure all necessary documents and information are accurately prepared and submitted.
3. Regulatory Updates: Ashab Group stays updated with the latest FSSAI regulations and guidelines. We provide clients with timely updates and guidance on any regulatory changes that may impact their operations or compliance requirements.
4. Consultation and Training: We offer expert consultation and training services on FSSAI regulations. Our team provides valuable insights and guidance on best practices for food safety, hygiene, labeling, and other areas of compliance to ensure clients maintain FSSAI compliance standards.
1. Export and Import Assistance: Ashab Group offers services to assist clients with their export and import needs. We provide guidance and support throughout the process to ensure smooth transactions.
2. Documentation and Customs Compliance: Our team helps clients with the preparation of necessary documentation for export and import activities. We ensure compliance with customs regulations and facilitate smooth customs clearance.
3. Regulatory Compliance: Ashab Group ensures that clients’ export and import activities are in compliance with relevant regulations and requirements. We stay updated on the latest regulatory changes to provide accurate guidance and support.
4. Logistics and Supply Chain Management: We assist clients in managing logistics and supply chain aspects of their export and import operations. Our team ensures efficient transportation, timely delivery, and overall optimization of the supply chain to meet clients’ needs.