Why Choose Us?
Finding the right service provider can be challenging, but we make it easy with our expertise, commitment, and customer-first approach. Whether you need top-notch solutions or reliable support, we ensure excellence in every aspect.
Expert Guidance
Affordable Pricing
Customer Satisfaction
Proven Results
Regulatory Strategy And Compliance
We offer comprehensive strategic advice and regulatory support to help you successfully navigate the complex approval processes required by regulatory bodies such as CDSCO, NPPA, BIS, CBN and FSSAI. Our services are designed to demystify regulations and ensure your products meet all compliance standards.
Our expert team will assist you in interpreting relevant regulations, providing clear guidance on how they apply to your specific situation. We work closely with you to develop tailored compliance strategies that align with your business goals and regulatory requirements. From the initial stages of product development through to the submission and approval process, we are with you every step of the way. We help prepare and review documentation, ensuring that all submissions are thorough and meet the necessary criteria for approval. Our goal is to streamline the regulatory pathway, minimizing delays and facilitating a smoother journey to market. With our deep industry knowledge and commitment to excellence, we empower you to focus on innovation while we manage the complexities of regulatory compliance. Let us be your trusted partner in achieving regulatory success.
Product Registration And Submission
Our expert team specializes in the meticulous preparation and submission of a comprehensive array of regulatory documents essential for bringing your products to market. We are well-versed in the intricacies of regulatory submissions, ensuring that each document meets the highest standards of accuracy and compliance.
Our Service Include
Investigational New Drug (IND) Applications
We assist in compiling the necessary data and documentation to support your IND submission, enabling you to initiate clinical trials safely and efficiently.
Subsequent New Drug Applications (SND)
We provide guidance on SND submissions, helping you navigate the requirements for modifications to existing drug products.
New Drug Applications (NDA)
Our team ensures that your NDA is thoroughly prepared, containing all required information to demonstrate the safety and efficacy of your drug, paving the way for regulatory approval.
Fixed Dose Combination (FDC) Applications
We help you prepare FDC applications by ensuring that all components meet regulatory criteria and that the benefits of the combination therapy are clearly articulated.
Various Forms:
We handle a multitude of specific forms required by regulatory bodies, including MD-3, MD-4, MD-7, MD-8, MD-12, MD-14, MD-16, MD-18, MD-20, MD- 22, MD-24, MD-26, MD-28, MD-33, MD-39,MD-41,COS-1, COS-4, COS-5, COS-12 and others, as well as submissions to the Food Safety and Standards Authority of India (FOSCOS).
Clinical Trial Permission Applications
Our expertise extends to securing permissions for clinical trials, ensuring that all necessary documents are in order for regulatory review.
We prioritize timeliness in our submissions, understanding the critical role that deadlines play in your development timelines. Our thorough review process ensures that all documents are not only complete but also tailored to meet the specific requirements of each regulatory body. By leveraging our expertise, you can focus on your core business objectives while we manage the complexities of regulatory documentation, facilitating a smoother path to market approval.
Quality Management
Systems (QMS)
We specialize in designing, implementing, and maintaining effective Quality Management Systems (QMS) tailored to meet international standards and regulatory requirements. Our comprehensive approach ensures that your organization not only complies with industry regulations but also enhances operational efficiency and product quality.
Our QMS Service Include
Custom QMS Design
We work closely with you to develop a QMS that is specifically tailored to the unique needs of your organization and the products you offer. Whether you are in the medical device, cosmetics, food, or pharmaceutical sectors, our systems are aligned with the relevant regulatory frameworks.
Implementation Support
Our team provides hands-on support during the implementation phase, ensuring that your QMS is integrated seamlessly into your existing operations. We guide you through the necessary steps to ensure all processes are documented, roles are defined, and staff are trained to adhere to the new system.
Compliance with International Standards
We ensure that your QMS adheres to international standards such as ISO 9001, ISO 13485 for medical devices, ISO 22000 for foods and ISO 22716 for cosmetics. By aligning your processes with these recognized standards, we help you enhance product safety and quality while improving customer satisfaction.
Regulatory Alignment
Our expertise ensures that your QMS meets the specific requirements set forth by regulatory bodies such as the CDSCO, and FSSAI. We stay updated on regulatory changes, helping you adapt your QMS accordingly to maintain compliance.
Ongoing Maintenance and Improvement
A successful QMS is a dynamic system that evolves with your business. We provide ongoing support to monitor and evaluate your QMS performance, facilitating continuous improvement. This includes conducting regular audits, identifying areas for enhancement, and ensuring corrective actions are implemented effectively.
Training and Capacity Building
We offer tailored training programs to equip your team with the necessary skills and knowledge to operate within the QMS effectively. Our training covers all aspects of quality management, including documentation practices, risk management, and quality control processes.
By investing in a robust QMS with our expertise, you can enhance product quality, ensure regulatory compliance, and foster a culture of continuous improvement within your organization. Let us partner with you to build a quality management system that not only meets industry standards but also drives your business success.
Audit And Inspection
Readiness
We prepare your organization for regulatory audits and inspections by conducting comprehensive pre-audit assessments and proactively addressing any potential issues. Our dedicated approach is designed to ensure that your operations are always in a state of readiness, enabling you to meet and exceed regulatory requirements with confidence.
Our Audit Preparation Services Include
Pre-Audit Assessments
We perform detailed evaluations of your existing processes, systems, and documentation to identify areas that may require improvement or adjustment before a regulatory audit. Our assessments are tailored to the specific requirements of the relevant regulatory bodies, whether they be SLA, CDSCO, FSSAI, NB or others.
Gap Analysis
Our team conducts a thorough gap analysis to compare your current practices against regulatory standards and industry best practices. This helps pinpoint any discrepancies or weaknesses that could lead to compliance issues during an audit.
Action Plans for Improvement
Based on our assessments, we develop actionable plans to address identified gaps and enhance your compliance posture. This may involve updating standard operating procedures (SOPs), enhancing training programs, or implementing new quality controls.
Mock Audits
We conduct mock audits to simulate the regulatory inspection process. This hands-on approach allows your team to experience the audit environment, understand what to expect, and practice responding to auditor inquiries. Our mock audits provide invaluable insights into your preparedness and areas for improvement.
Training and Education
We offer targeted training sessions for your staff to ensure they are well-equipped to handle audits effectively. This includes educating your team on audit protocols, documentation requirements, and best practices for communication with auditors
Ongoing Support
Our commitment doesn't end with the audit preparation. We provide ongoing support to help you maintain compliance after the audit, ensuring that corrective actions are implemented and that your organization remains aligned with evolving regulatory standards
Post-Audit Follow-Up
In the event of an actual audit, we offer post-audit support to help you address any findings or observations. Our team assists in developing responses to regulatory feedback and implementing necessary corrective actions to prevent future issues.
By partnering with us, you can enhance your organization's readiness for regulatory audits and inspections. Our thorough preparation process not only minimizes the risk of non-compliance but also fosters a culture of quality and accountability within your organization. Let us help you navigate the complexities of regulatory oversight with confidence and ease.
Training And Development
We offer customized training programs specifically designed to enhance your team’s knowledge and skills in regulatory affairs and quality assurance. Our training initiatives are tailored to meet the unique needs of your organization, ensuring that your team is well- equipped to navigate the complexities of compliance in a rapidly evolving regulatory landscape.
Key Features of Our Training Programs
Tailored Curriculum
Our training programs are developed based on a thorough assessment of your organization’s specific needs, challenges, and goals. This ensures that the content is relevant and applicable, maximizing the effectiveness of the training.
Focus on Regulatory Affairs
We cover a wide range of topics in regulatory affairs, including understanding regulatory frameworks, submission processes, and compliance strategies. Our programs help your team stay informed about the latest regulations and best practices, empowering them to make informed decisions.
Quality Assurance Expertise
Our training delves into the principles of quality assurance, including quality management systems, documentation practices, risk management, and continuous improvement. We equip your team with the tools and knowledge necessary to maintain high-quality standards in your operations.
Industry Updates
The regulatory landscape is constantly changing. Our programs include updates on the latest industry practices and regulatory changes, ensuring that your team is always up to date with current requirements and trends.
Hands-On Learning
We incorporate practical exercises, case studies, and real-world scenarios into our training sessions. This interactive approach helps reinforce learning and allows participants to apply their knowledge in practical situations.
Flexible Delivery Options
We offer flexible training delivery methods, including in-person workshops, online courses, and hybrid models, allowing you to choose the format that best suits your team’s needs and availability.
Support for Food Safety Supervisors
As part of our commitment to food safety, we help to provide specialized training for Food Safety Supervisors under the FoSTaC Training Programme. This program is designed to equip supervisors with the necessary skills to ensure food safety compliance in their operations, focusing on critical aspects such as hygiene, sanitation, and risk management.
Global Certifications
We specialize in facilitating the process of obtaining ISO certifications, including ISO 9001, ISO 22000, and ISO 14001, along with various product certifications from both accredited and non- accredited bodies. Our comprehensive services are designed to help your organization achieve and maintain compliance with global standards for quality, safety, and environmental management.
Authorized Agent In India
Overview of Authorized Agent for Cosmetics When a foreign company seeks to enter the Indian market but does not have a physical presence in India, it can appoint an authorized agent to register and market its products.
An Authorized Agent is an individual or entity in India designated by the foreign company to act on its behalf. This agent will be responsible for all import and business activities related to the foreign company’s products in India, ensuring compliance with the provisions of the Drugs and Cosmetics Act 1940 and Cosmetics Rules 2020. Register with FDA RAQA SOLUTIONS for Cosmetic import RC! Form Cos 2 facilitates the registration of cosmetics under the Cosmetics Rules 2020 and the Drugs and Cosmetics Act of 1940, as established by CDSCO. As your Authorized Agent, FDA RAQA SOLUTIONS will manage all necessary documentation in compliance with national, state and district guidelines regarding labeling and marketing.
ISO 22000 (Food Safety Management)
For organizations in the food industry, we facilitate the certification process for ISO 22000, which outlines the requirements for a food safety management system. Our team assists in developing a framework that ensures food safety throughout the supply chain, from production to consumption, helping you meet regulatory requirements and protect consumer health.
ISO 14001 (Environmental Management)
We support organizations in achieving ISO 14001 certification, which focuses on effective environmental management. Our approach involves assessing your current practices, identifying environmental impacts, and implementing strategies to improve sustainability, compliance, and overall environmental performance.
Tailored Certification Pathways
Understanding that each organization is unique, we provide customized pathways to certification based on your specific goals, industry requirements, and existing processes. Our experts work closely with your team to develop a certification plan that aligns with your organizational objectives.
Documentation and Process Development
We assist you in creating and refining the necessary documentation and processes required for certification. This includes developing quality manuals, standard operating procedures (SOPs), and process workflows to ensure compliance with ISO standards.
Liaison with Certification Bodies
We act as a liaison between your organization and certification bodies, facilitating communication and ensuring a smooth certification process. Whether dealing with accredited or non-accredited bodies, we help you navigate the requirements and expectations of each.
Ongoing Support and Maintenance
Achieving ISO certification is just the beginning. We provide ongoing support to help you maintain compliance, including periodic audits, reviews, and updates to your QMS as needed. Our commitment ensures that your organization not only meets but exceeds the standards required for sustained certification.
Other Services
Legal Metrology, NPPA, BIS & CBN “FDARAQA SOLUTIONS provides comprehensive support to businesses across the full spectrum of legal metrology, encompassing registration, licensing, product approvals, stamping, verification, and label compliance.” Registration For importers Registration of Manufacturers and Packers Manufacturer license Dealer license Repairer license BIS certification for foreign manufacturer in India etc.,