Quality & Regulatory

CMC Technical Operations > Services > Supply Chain > Quality & Regulatory
  • Quality Agreements
  • Vendor audit service
  • Quality risk assessment
  • PAI readiness consulting
  • Regulatory document writing, reviewing, and editing
  • Experience with IND, IMPD, NDA, MAA and PAS filings
  • Support with briefing booklets for health authority interactions
  • FDA meeting prep
  • Gap analysis for regulatory submissions

Setting New Standards in Quality and Regulatory Excellence

Quality and regulatory compliance are foundational to what we do at CMC Techops. At CMC Techops, it is our commitment to rigorously adhere to regulatory standards and the world’s highest quality standards, meaning every product we create, in every market, adheres to, or exceeds, global compliance market standards. We have Quality and Regulatory teams dedicated to hard work that function in synergy to see that all development and manufacturing practices are in parallel with the CGMP regulations and international regulatory expectation.

Our Approach to Quality Management

Our supply chain strategy is around optimizing processes from procurement and logistics to distribution. Utilizing a proactive (and data-driven) approach, we anticipate and mitigate supply chain risk, so that your projects continue to proceed on time and within budget. From robust quality assurance and regulatory compliance protocols to every stage, we deliver a risk-managed supply chain solution that is relevant to your requirements.

  1. Quality Assurance (QA) : Our QA team ensures the quality and safety of all processes and products from design through development by using detailed Standard Operating Procedures (SOPs) and a Quality by Design (QbD) philosophy to identify and manage CQAs and CPPs. This minimizes variability, increases product confidence, and improves compliance consistency.
  2. Quality Control (QC) : We have dedicated QC laboratories with state-of-the-art analytical instrumentation enabling extensive, thorough testing and quality assessment of raw materials, intermediates and finished drug products. Physical, chemical and microbiological tests are performed to demonstrate that each product performs as expected and defined in the specifications for purity, potency, stability and safety. We utilize compendial methods from pharmacopoeias including but not limited to USP, EP, JP etc. In addition, we also develop and validate custom methods as per project-specific requirements. Our QC testing portfolio ranging from HPLC and GC to dissolution and microbial testing ensures that each batch is in compliance with required regulations.
  3. CGMP Compliance and Risk Management : Compliance with Current Good Manufacturing Practices (CGMP) is our way of working. We design, validate and monitor our processes to consistently meet regulatory requirements. Our quality systems use risk-based approaches to proactively detect potential non-compliances and define and implement CAPAs.

    We perform extensive audits of both our internal departments and our partner network of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) to ensure CGMP compliance, enable continual improvement, and maintain the highest standards of quality. We continually improve our processes through routine risk assessments, internal audits, and cross-functional training to identify and prevent risks before they can affect product quality or safety.

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Regulatory Affairs Expertise

  1. Global Regulatory Strategy Development : Our team will design a regulatory strategy tailored to your specific needs. We will perform a complete regulatory assessment and gap analysis, considering country requirements and potential hurdles in countries such as the U.S., Europe, and Asia, with the aim of expediting regulatory approval while adhering to local and international regulations. We support multiple regulatory submissions including IND, NDA, BLA and ANDA. Our team of regulatory specialists work very closely with clients to make sure the submission is filed on time successfully
  2. CMC Documentation and Submission Support : Chemistry, Manufacturing, and Controls (CMC) documentation is essential for securing regulatory approval of new drug products. Our team offers CMC writing services that include module preparation in the Common Technical Document (CTD) format. We provide reliable and detailed information on manufacturing processes, controls, and specifications. We make certain that all CMC submissions are not only complete and well-organized but also full ICH Q8-Q11 or similar guideline-compliant. Our Regulatory Affairs team supports regulatory query responses to avoid approval-phase delays.
  3. Compliance with Global Standards : At CMC Techops we take the highest regulatory guidance from the FDA, EMA, ICH and WHO; Our Quality systems are designed to assure compliance with prevailing regulations while allowing for rapid adoption of evolving requirements. We keep a completely transparent approach where our clients have access and visibility to all compliance activities and documents. We keep track of regulatory changes and follow the industry trends so that we can anticipate any modifications that would affect compliance and we can change our processes accordingly. Knowing that such a mindset cultivates competitive advantage, CMC Techops ensures that the products being developed and manufactured meet international standards allowing for the introduction of those products to various regions.
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Key Components of Our Quality and Regulatory Systems

  1. Analytical Method Validation : Our analytical method validation services guarantee that all test methods used in quality control are correct, accurate, and reliable. We perform method validation by ICH guidelines including, but not limited to, specificity, linearity, accuracy, precision and robustness. Any process that does not pass through the validation undermines the structure of our quality control systems and increases the risk of batch failure and product recall.
  2. Stability Programs : Stability testing is important in establishing the shelf-life of drug products and the conditions under which they should be stored. We examine product stability under ICH conditions; this involves stressing the samples by exposing them to accelerated temperature and humidity conditions and storing them at room temperature for long periods. Our stability programs are created to meet these regulations and to generate data for product registration in various markets. As our stability services, we have real-time monitoring and periodic reporting of the product stability to inform the clients of the status of their products during the testing phase. We also provide a stable assay for the initial determination of degradation products for the formulation of the drug product.
  1. Document Control and Traceability : The management of documents is crucial to have effective quality and regulatory management. All records which include batch records, standard operating procedures and audit reports can be safely stored, accessed and tracked within our document control systems. We operate computerised systems that meet adequate requirements for electronic records and signatures under 21 CFR Part 11 hence boosting data credibility. Documentation is performed at the beginning, middle and end of each project phase so that our clients have records of all activities and decisions regarding development or manufacturing. This traceability is important, especially during regulatory audit processes and goes a long way in making most processes accountable.

4.Commitment to Continuous Improvement and Compliance

Improving quality and compliance processes is an ongoing agenda in CMC Techops. It is here that our teams are constantly training and upgrading their technology, as well as implementing process improvements to be in line with industry giants within the pharmaceutical sector. We periodically perform internal assessments, as well as undertake external assessments to assess the sustainability of the established compliance to international standards and to define further improvement potential of quality management systems.

Why Choose CMC Techops for Quality and Regulatory Excellence?

  1. Unwavering Commitment to Quality: Quality is maintained within the foundation of our company. We have strong processes in place that uphold; check, order, dependability and alignment with standards in projects.
  2. Experienced Regulatory Affairs Team: We have senior staff with over a decade of experience providing regulatory affairs services to global markets, providing comprehensive advice and direction to our clients.
  3. Proactive Compliance Management: It also means that our approach to risk management and compliance is rather rigorous and we guarantee a top-quality product in terms of its safety and effectiveness.
  4. Transparency and Accountability: We work with the principle of free communication and it is an absolute transparency with the customer. Here we correctly guide you through the development and manufacturing process to help you obtain accurate information.