Preclinical
Pharmazone carries extensive experience and expertise in pre-clinical phase consulting services which typically involve providing guidance and support to pharmaceutical, biotechnology, and medical device companies during the early stages of drug or medical product development, before clinical trials begin.
Pre-clinical phase consulting services
Assisting with regulatory strategies, ensuring compliance with applicable regulations, and preparing regulatory submissions to health authorities.
Helping to design pre-clinical studies, including animal testing protocols, to gather data on safety, efficacy, and pharmacokinetics
Providing expertise in toxicology studies to assess the safety profile of the product candidate.
Providing expertise in conducting pharmacological studies to evaluate the mechanism of action, dose-response relationships, and potential therapeutic benefits
Offering support for bioanalytical method development and validation to measure drug concentrations in biological samples
Analyzing pre-clinical data and assisting in interpreting results to make informed decisions about advancing the product candidate.
- Ensuring that pre-clinical studies are conducted in compliance with GLP regulations and industry standards
- Providing monitoring and auditing services at any GLP Labs
- Identifying potential risks associated with the product candidate and developing strategies to mitigate these risks.
Overseeing pre-clinical activities, timelines, and budgets to ensure efficient progress toward clinical development.
Assisting with the preparation of pre-clinical study reports, regulatory documents, and scientific manuscripts for publication
Assist pharmaceutical companies in preparing and formatting regulatory documents according to the specific requirements of regulatory agencies such as the FDA, EMA, PMDA, and others. This includes Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and variations.
Submissions and Publishing services help compile and organize regulatory documents into submission-ready formats, ensuring completeness, accuracy, and consistency. We also provide document management systems or software platforms to facilitate version control, document tracking, and collaboration among stakeholders.
We offer strategic guidance and support for planning regulatory submissions, including timeline development, regulatory strategy formulation, and risk assessment.
With the increasing adoption of electronic submission formats such as eCTD (electronic Common Technical Document) and NeeS (Non-eCTD electronic Submissions), Submissions and Publishing services. Pharmazone specializes in Preparing, Validating, and Submitting electronic regulatory dossiers in compliance with regulatory standards and technical requirements.
Submissions and Publishing services facilitate interactions with regulatory authorities by coordinating meetings, preparing briefing documents, and responding to regulatory queries during the review process.
Beyond initial submissions, by these services support lifecycle management activities by managing post-approval submissions, variations, renewals, and updates to regulatory dossiers throughout the product lifecycle.
Pharmazone’s Submissions and publishing services also assist in the publication of regulatory documents in scientific journals, regulatory databases, and public repositories. This involve formatting manuscripts, ensuring compliance with journal guidelines, and managing the submission and review process.
Our submissions and publishing services adhere to stringent quality assurance processes to ensure the accuracy, integrity, and compliance of regulatory documents with regulatory requirements and industry standards. This includes thorough document review, verification of data accuracy, and adherence to submission timelines.