CPPL has a skilled GMP team that is well-known for its expertise in the field. We have extensive knowledge of guidelines and requirements and provide valuable advice to clients on areas of compromise. It is important to note that we charge a fixed consultancy fee, rather than operating on a commission basis, to ensure clients are not burdened by unnecessary delays. We actively recommend reliable vendors, assist in machinery selection, and negotiate favorable prices for essentials like machinery and AHU systems. We have successfully designed 15 plants in India and provided technical guidance to numerous manufacturers.
A Periodic Safety Update Report (PSUR) is a pharmacological document designed to give regulatory authorities an update on a medicinal product's global safety experience at predetermined intervals after authorization.
The Periodic Safety Update Report for marketed drugs, commonly referred to as PSUR, serves as an autonomous document that facilitates a thorough assessment of the global safety data for a specific marketed drug or biological product. It holds significant importance in identifying potential safety concerns, evaluating changes in the risk-benefit profile, effectively communicating risks to regulatory authorities, and determining the necessity for risk management measures. Moreover, the PSUR acts as a monitoring tool to assess the effectiveness of these initiatives. It is crucial to note that the PSUR process entails multiple steps, including the collection and processing of adverse drug reaction information, retrieving and analyzing data, conducting medical reviews, and assessing potential risks. These processes heavily rely on having adequate resources at hand. It is imperative to adopt a proactive approach throughout the PSUR process to identify essential stages and comprehend the ramifications of any potential errors. Utilizing this knowledge, thorough planning, integrating quality into each step of the PSUR process, and monitoring performance can considerably raise the likelihood of producing a high-quality report. Conversely, any shortcomings in key PSUR processes will result in a substandard report that fails to provide valuable insights into emerging safety signals or, worse, provides misleading information that can pose risks to public health.
CPPL offers a range of valuable services to your organization. We prioritize cost-saving measures and provide honest assessments to ensure that we never suggest impractical and costly solutions. We only propose what is necessary and mandatory, understanding that our clients' growth is crucial to our own success as consultants. At Cyclone Pharmaceuticals Pvt Limited, we believe that QUALITY, COST, and TIME are key factors for achieving success. We recognize that small-scale manufacturers may find the dossier compilation and writing process overwhelming. It is important to note that dossier writing requires technical skill and involves a thorough review of clients' technical documents, while compilation is a more straightforward formatting task that can be handled by non-technical individuals. CPPL guarantees adherence to regulatory norms through our highly skilled technical staff and our extensive industrial experience.
Cyclone Pharmaceuticals Pvt Ltd, also known as the Pharmaceutical Consultants of India, offers comprehensive assistance at every stage of regulatory compilations, document creation, and document submission. Our team of experts specializes in QA, QC, Production, and Regulatory sectors, setting us apart from other consultants. As a result, reviewing documents, compiling dossiers, and addressing inquiries is an effortless task for our company. We take pride in delivering regulatory consultancy services of the highest quality and at the lowest cost. Our compiled documents have been consistently accepted by regulatory authorities without any queries. Additionally, our team remains vigilant in staying updated with the latest regulations, ensuring our ability to provide impeccable Drug Dossiers, DMF, CTD, ACTD, KDMF, USDMF, eCTD, EUDMF, USDMF, and other format compilations. Moreover, we are uniquely positioned to fulfill all your pharmacovigilance requirements and assist your company in implementing any necessary Corrective or Preventive Actions (CAPA) based on a 'RISK'-based methodology, regardless of the stage your product is in its lifecycle for pharmacovigilance activities. With our specialization in pharmacovigilance services, Cyclone Pharma can also provide experienced auditors to meet your global auditing needs.