Minerva Regulatory Consulting

Minerva Regulatory Consulting is listed as a small consultant research supplier in the Scientist.com network, with 1 site in 1 country.

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Type of company: Small consultant

Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services
ICH-compliant stability testing Perform ICH-compliant stability testing
Impurities in Drugs Risk Assessment Create a risk-based control strategy to determine any toxic elemental impurities that may be present in human medicines.
Regulatory Starting Materials Sourcing regulatory starting materials (RSM)

Clinical Study Reporting (CSR) Report results of clinical trials to regulatory agencies. This includes participant flow, baseline characteristics, outcome measures, statistical analyses, and adverse events.
Clinical Trial Consulting Consulting services for Clinical trials.
Data & Risk Management Determine the extent of the risk and the reliability of the data used to access the aforementioned risk.
IND Writing Consulting Consulting for an Investigational New Drug Application
Regulatory Compliance & Documentation Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.

Informed Consent Development Informed Consent is a prerequisite of any conduct within a clinical trial, and refers to the process in which the permission of the potential clinical trial subject is obtained. Informed consent applies to all...
Phase 1-3 Studies Design phase 1-3 studies that seek to identify if a drug is safe, effective, and more efficient than other available treatments on the market.
Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
Regulatory Operations Ensure that all specific regulatory documents are published and properly organized before submission.

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Chemistry, Manufacturing and Controls (CMC) Consulting Consultant services related to the development of pharmaceutical and biopharmaceutical drug products that are consistently effective, safe and high quality for consumers.
Consulting Services Work with consultants who provide expert advice in various areas of research and technology.

Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND) Dossier Develop and submit Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND) Dossier
Nominated Signatory for Technical Review and Regulatory Sign-off Official, qualified medical or scientific professional responsible for reviewing and approving materials to ensure compliance with regulatory and legal standards.
Regulatory Submissions and Compliance Draft, format, and submit documents to Pharmaceutical approval agencies according to documentation and guidelines. This includes documents such as NDAs, INDs, SUSARs, AE reporting, RMPs, and PSURS.
Target Product Profile (TPP) A sponsor prepared document which summarizes the drug development program that is described in terms of the labelling concepts. This profile is a communication method used between the FDA and sponsor which can be used...

IND/CTA Authoring and Publishing Services IND/CTA authoring and publishing services involve preparing, compiling, and submitting Investigational New Drug (IND) applications or Clinical Trial Applications (CTA) to regulatory authorities, ensuring compliance...
Pharmacovigilance Literature Surveillance Conduct systematic and ongoing review of scientific and medical literature to identify new information about the safety profile of a drug. This process is crucial for detecting adverse drug reactions (ADRs) that may...
Regional Regulatory Consulting Regional regulatory consulting provides expert guidance on local regulatory requirements and processes to help companies navigate and comply with the specific rules and standards of different geographical regions...

Dossier Prep. and Consultancy Assistance with creation of a regulatory document that contains all the Clinical, non-clinical, and CMC information of a pharmaceutical product to be approved, registered, or marketed within a specific country.

Life Cycle Management Plan and strategy of the data collection and information throughout the different phases of product development (portfolio assessment, pre-clinical trials, clinical trials, pre-authorization, post-authorization, and RWE)
Preparation Of Regulatory Dossiers Preparation of regulatory dossiers is the process of compiling detailed administrative, clinical, and scientific data into a standardized format
Regulatory Submission Documents Request services related to the submission and writing of New Drug Applications (NDA), Investigational New Drugs (INDs), and Investigator Brochures (IB) to the FDA and other regulatory bodies.
Strategic Regulatory Advice Strategic Regulatory Advice involves expert guidance that helps businesses navigate complex legal and industry standards to achieve market access and maintain compliance. It serves as a blueprint for aligning business...

Environmental Risk Assessment Conduct EU and US Environmental Assessment (ERA/EA) phases one and two according to VICH guidelines.

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