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Here are some areas of expertise within our firm:
 
Quality and Compliance
 
Quality Control services range from providing interim management and oversight of your QC department to completing key projects. Here are some of the services offered in this arena:
  • Audit raw material vendors and testing facilities
     
  • Develop Test Methods. Assist with method transfer, ILQ and method validation.
     
  • Develop process controls and product specifications
     
  • Design the stability program suitable for your product and its stage of development
     
  • Establish reference materials
     
  • Evaluate test methods and methods validation
     
  • Assess laboratory controls and compliance
     
  • Provide interim management and oversight for clients without internal staff
Quality Assurance, GMP
  • Develop Phase Appropriate Quality Systems including Quality Master Plan, SOP's, Forms, Checklists and other documents
     
  • Provide resources for review of executed records such as Batch Records, Analytical Test results, Packaging Records and others
     
  • Provide a "Person in the Plant" for critical manufacturing and packaging runs
     
  • Audit raw material vendors, control (compliance) systems, manufacturing facilities (contract and in-house), testing facilities, labeling and packaging facilities, and holding and distribution facilities
     
  • Evaluate validation of facility systems, equipment, cleaning and production processes
     
  • Review and assist in the preparation of the Chemistry, Manufacturing and Controls (CMC) sections of New Drug Applications (NDAs), Biologics License Applications (BLAs) and Development Reports
     
  • Preparation for pre-approval and biannual inspections, including mock FDA inspections
     
  • Provide interim management and oversight for clients without internal staff
     
  • Provide resources to audit vendors for in-licensing and out-licensing due diligence
Quality Assurance, GCP/GLP
  • Perform GCP and GLP audits and complete QA review, including reports, protocols and Investigator Brochures
     
  • Perform systems audits of the clinical trial safety database to assess risk management
     
  • Develop GCP and GLP training programs
     
  • Develop appropriate Quality Systems to ensure compliance with GCP/GLP requirements
     
  • Perform due diligence investigations for regulatory and clinical trial strategy assessment
     
  • Provide interim management and oversight for clients without internal staff
Formulation and Early Stage Development
  • Provide expertise on formulation development to minimize re-loops
     
  • Extensive experience in developing drug delivery technologies including topical, intranasal, transdermal patch, oral controlled release, and injectable formulations for new molecular entities and existing drug compounds
     
  • Guidance on excipient compatibility tests, stability studies, compendia materials, method of manufacture
     
  • DOE methodologies and interpretation
Analytical and Product Development
Regulatory Affairs
  • Write, review and post-submission support
     
  • provide innovative drug/biologic development strategies to meet corporate goals
     
  • Provide strategic guidance, personnel training, and expert review of regulatory submissions
     
  • Provide interim management and oversight of your Regulatory Affairs department
     
  • Accompany you to meetings with regulatory authorities to represent you or to provide impartial outcome analyses
     
  • Perform due diligence assessments for in-licensing opportunities
Manufacturing and Supply Chain
  • Provide guidance on selection of Contract Manufacturing Organizations (CMO's), Contract Laboratories, Packagers
     
  • Provide due diligence efforts on potential in-licensing or M&A activities
     
  • Conduct gap analysis internally for potential out-licensing opportunities
     
  • Provide "Person in the Plant" for critical manufacturing and packaging runs
     
  • Transfer technology process to another facility or contract manufacturing organization
     
  • Develop and negotiate Supply Agreements
     
  • Write/review relevant sections of Chemistry, Manufacturing and Controls section
     
  • Draft phase specific documents such as Batch records, Production Forms, Checklists, Protocols, Reports and others
     
  • Provide interim management and oversight for clients without internal staff
Project Management
  • Provide leadership in defining tasks, resources, contingencies, deliverables etc to create a plan that aligns the organization
     
  • Create and manage tools to focus the organization on key tasks and milestones
     
  • Track budgets for multiple activities both internally and externally
     
  • Flag and meliorate risk areas that are behind schedule, have cost overruns, need resources or are on critical path to ensure that adequate control is exercised to remedy the issue
     
  • Provide "forward visibility" on expected activities, risks, decision points, expected costs etc. to allow appropriate planning to occur to meet future demands
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