Pharmaceutical products refer to all biological and drug candidates, existing chemical compounds or products being researched (new chemical entity: NCE per section 505b of the US Food, Drug & Cosmetic Act). These products are developed, manufactured, packaged, labeled, stored, tested and distributed in compliance with Good Manufacturing Practices requirements under applicable country law, including those relating to investigational and clinical use.
Biologics (biosimilars for generic form) are special class of pharmaceuticals that have been produced from or contain components of living organisms such as sugars, proteins, nucleic acids, or a combination of these substances. They include a wide range of products such as vaccines, gene therapy, allergenics, and recombinant therapeutic proteins and may be used for the treatment of medical conditions for which no other treatments are available.
The aseptic manufacture, characterization, control and stability of these active substances is critical to human safety. AXSource consultant have hands-on knowledge, expertise and experience in the development and commercialization of these products. These products have included blood, blood-products e.g. artificial blood substitute, novel vaccines, oncology products etc.
AXSource has supported manufacturers or drugs and biologics, importers, distributors, wholesalers, CROs, laboratories, universities, packagers, labelers and related industry clients, in their successful navigation through complex pre-clinical, clinical, regulatory and quality processes by providing cost-effective & compliant solutions to expedite product launches in global markets.
Our customers have ranged from large multi-national companies to start-ups. We have supported our clients with full product life cycle regulatory services from research to commercialization.
Life Cycle of Regulatory Activities
|Stage||Major Quality Objectives||Major Regulatory Objectives|
|Research & Development||“Good Laboratory Practices”||Enhanced Product Quality for pilot batches|
|Pre-Clinical||Good Laboratory Practices Documentation Development
GLP Training (Implementation)
Certification with Standards Council Canada (SCC)
Investigational New Drug (IND) Submissions
|Clinical||Good Clinical Practices Documentation & Implementation
GCP Audits/ Clinical Monitoring
Control of clinical supplies
Facility Project Management & Validations (WFI, DI, ClP/SIP, Cleaning, clean room, laboratory methods, Autoclave, Depyrogenation)
|Supporting regulatory applications
Phase I, II, III/IV Clinical Trial Applications
Adverse Drug Reaction/ Event Reporting
Hosting Inspections & Remediation efforts
|Manufacturing, wholesale, importation, distribution||Good Manufacturing Practices Documentation Development
Custom GMP Training
Software & Computer System Validation
Drug Establishment licenses (DEL)/Amendments
Virtual Quality Control/ QA Service to Release Product
Coordination of Biologic Lot Release with Agencies
|New Drug Submissions (NDS)
New Drug Application (NDA) Submissions
Biologics License Applications (BLA)
Marketing Authorizations (EMA)
Regulatory application amendments/variations
|Export Control||Quality Management System
Audits & Inspections