Intellectual Property
Magothy Consultants have extensive experience in Intellectual Property development, including specification development and as a fact witness in defense of issued patents. In addition, we have expert witness experience in patent litigation cases, including Expert Reports, deposition, and court testimony.
Drug Product
Our drug product consultants have a substantial background in formulation & process development, scale up, and commercialization of various drug products. We can guide:
- Pre-formulation and developability assessments of NCEs
- Appropriate solubilization strategies for poorly soluble compounds
- Feasibility assessments for extended release applications
- Pediatric formulation development with specific expertise developing ODTs (Orally Disintegrating Tablets)
- Use of fit for purpose clinical compounding options to fully vetted commercial ready market image formulation and manufacturing planning
- NDA level formulation and process development programs and reports
- Selection and setup of clinical and commercial supply chain options
- Strong and fully integrated analytical method and specification input
- Product & process risk analyses
- Packaging development
CMC Regulatory
Magothy consultants have extensive experience in drug product development, including the associated regulatory briefing documents, meetings, dossier preparation and defense. These activities include:
- Gap analysis and regulatory risk assessments
- Briefing document preparation and review
- Investigational New Drug Application (IND) and IMPD development and review
- CTD Module 3 development and review, including NDA, MAA and ROW filings
- Quality Overall Summary (QOS) preparation and review
- Authoring and review of regulatory documents
- Regulatory defense preparation, review, and participation
- Annual Report preparation
Due Diligence
Magothy Consultants unique background allows us to provide our clients with detailed and thorough due diligence audits. We help clients through:
- Assessment of organizations and facilities for compliance with cGMPs and current regulations
- Review and analysis of formulation and process development, analytical development and stability, and regulatory status
- Identification of deficiencies and gaps in compliance and provision of remediation plans
- Provision of due diligence reports
- Support in due diligence discussions with potential collaboration partners
- Evaluation of supply chain and alternate site identification
Drug Substance
We have expertise in process chemistry to support phase-appropriate chemical and process development, including:
- Route scouting and selection
- Regulatory starting material definition
- Process evaluation and scale-up
- Analytical method development and evaluation for in-process testing and drug substance release
- Potential Genotoxic Impurity (PGI) evaluation and review
- Technical transfer
Project Management
We provide project management support for:
- CMC and Technical Development
- Clinical Trial Material (CTM) Supply Management
- Regulatory filings and Briefing Packages
- Supply Chain Management
We can provide structure to better delineate deliverables and project milestones with activity oversight, project planning, and coordination.