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Contract manufacturing is a phrase that refers to when a pharmaceutical company utilizes the manufacturing facilities of another company to produce medicines under their trademark. Contract manufacturing, often known as private label manufacturing. Contract manufacturers' services are not restricted to production. They also offer a variety of other services, including pharmaceutical stability studies, production, production of compliance papers in accordance with FDA regulatory requirements, preparation of end-stage clinical study items, and pre-formulation.
SK Health Care Formulations offers contract manufacturing services to pharmaceutical firms and hospitals for the purpose of producing goods beneath their brand/private label. This is in compliance with your country's regulatory standards.
Preclinical research is a risk management method used in drug development to determine the effect of a medication on mammals and extrapolate the probable consequence in humans. Preclinical investigations, such as toxicological and pharmacologic reactions to the medication at various doses, aid in the advancement of human volunteer research.
To maintain regulatory compliance and allow the medication research to continue, the sample collecting and laboratory environment must adhere to established criteria of facility maintenance, therapeutic ethics, and safe dose. The proper preclinical contract research organization meets or surpasses these objectives, allowing for expedited clearance of this preliminary phase of drug development. Additionally, the insights acquired during preclinical testing aid in the subsequent streamlining of medication development.
SK Health Care Formulations can assist your firm in developing pharmaceuticals product development plans, from leading candidate identification through final regulatory filings and post-market operations. Our worldwide vision and scientific knowledge will assure your development program's success by increasing its efficiency and manageability.
Services for Pharmaceutical Product Development:
SK Health Care Formulations has assisted businesses in determining the most suitable licensing solutions and in applying for and obtaining the necessary licenses and permissions for over several years. We will guarantee that your licensing requests are filed in accordance with Health Canada requirements by utilizing your technical documentation. Depending on your product, we can assist you with the following:
We provide a comprehensive variety of patent filing and prosecution services. We employ a large number of individuals who hold graduate degrees in chemistry and the biological sciences. Our patent experts and agents have prepared and filed patent applications for specific molecular medicines, biologics, bioinformatics, personalized medicine, polymorphisms, and diagnostic techniques. Moreover, we can aid you in seeking patent rights amendments due to delays at the patent office or regulatory body.
We can serve you with pre-issuance filings, re-examinations, intra components review, and post-grant audit. Also, we support patent holders with additional exams and re-examinations to ensure the robustness and legality of their inventions.
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