Our Services Home How We Are Different Our Services Case Studies About Our Name Contact Us   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   Copyright © 2009-2021, Ally CMC, All rights reserved.  Site design & host: NeuronLinks, Inc.