AxSource is your healthcare and Information Technology solutions provider specializing inconsulting services for pharmaceutical, biologics, medical device, natural health products, cosmetics and food industries. 1
2AxSource provides clinical, regulatory, compliance, quality assurance,quality control, engineering and IT business solutions to thepharmaceuticals, biologics, natural health product, medical devices,cosmetics, healthcare, information technology and allied industries.We specialize in start-up operations and new product launches for all youractivities in emerging markets. AxSource consists of a team of highlyqualified consultants who have committed decades of professionalexperience in North America, Mexico, Europe & Asia. The Group isexclusively dedicated to providing• Regulatory Affairs /Clinical Affairs• Quality Control & Assurance• Process Validation &• Information Technology services IT & Healthcare Consulting for past 20 years.
3AxSource Consulting Inc. shall be recognized as a progressive and ethicalenterprise capable of delivering true consulting and professional regulatoryaffairs & compliance services.We will partner with global regulatory agencies and industry associations to support our clients.We will engage with our clients in order to deliver cost-effective, safe and effective solutions.We will exceed our customer expectations in delivery of all our projects.
4 GMP, GCP PharmaRegulatory & GLP & ISO Clinical Validations Services Pre- Quality & ERP & Device Inspections Compliance Software Computer System IT Product System Integrations Development ValidationsPharmacovigil Litigation & Training & iance Contracts Development
5Competency, We are experts in what we do. Our expertise has been demonstrated overknowledge & and over. With over 150 cumulative years in business experience. Seniorexperience Consultants with over 15 years of industry experience. We have highly satisfied clientele. When AxSource assists in theSatisfied, reference- certification & implementation efforts, both employees and top managementable clients are satisfied. We are committed. There is a commitment between the company and theStable, experienced employees at AxSource. This means stable project teams, depth ofteam experience and mature processes. We are a global player. AxSource can execute projects globally. We canFlexibility and mobilized consultants & multi-disciplinary teams to assist you whether yourreach project is large ($50M) or small ($5K). We think of your bottom line. We provide consulting advice in closeCost-conscientious collaboration with our clients utilizing client resources as much as possible. AxSource supplies leadership, direction and path to successful outcomes.
6Broad experience in compliance in regulated health industry from low risk to high riskSenior consultants (>15 years) with global compliance and consulting expertiseBroad experience spanning R&D, pre-clinical/clinical, manufacturing, importation,distribution/logistics, sales, marketing and customer service and post marketingprocessesOnly health products consulting group in Canada with in-house IT expertsGround level design planning start ups to valuable risk management services forclients with marketed productsRQBI™ service offering for more mature companies for efficiency and costmanagementTrue “Consulting” and professional services servicing over 50 clients worldwideProject Management and leading large scale compliance projects in Canada, USA,Mexico, Europe and Asia (China & India)Current knowledge of technology and process accelerators to optimize qualityOften requested to supply staff for expert opinions in litigations
7Leverage our partnerships (CROs, Validation, ISO and Legal) 2 Clinical Research organizations (Clinical Studies, Medical writing) as partners in Canada & India Information Management & Validation of critical systems in manufacturing, supply chain and medical devices Process Engineering & Validation (13 Engineers) Learning & Development experts ISO & Third Party Certification (Notified Bodies) organization for medical devices
8Our success comes down to the following attributes Ability to adapt to a range of different business sectors within the regulated health products industry worldwide Pragmatic problem solving to mitigate risks Innovative approach with lowest business impact Customer integrated teams Mentoring and coaching for smooth transition Honest & ethical foundation Strong communication skills On-time project delivery Client Satisfaction
Our RQBI™ Service 9 In-depth multi-disciplinary review of inputs and outputs of • Your Business and Customer needs • Your Regulatory strategy • Your Financial goals related • Your Quality & Compliance Resulting in • Cost efficiency • Improved regulatory strategy • Meeting Management Goals
10Legal, Regulatory & Clinical QA/Compliance Product Submissions for Drugs/ Biologics/ NHPs/ Medical devices (Canada, US, EU) GxP Design (GCP, GMP, GLP) NDS, ANDA, 510K, CTA, PMA, DIN, Master Files, New Drug, biopharmaceutical, Device, NHP, Device Submissions (Class I-IV), NHP (PLA & SLA) Cosmetic for new and existing facilities per global harmonized requirements Facility Licensing & Registration (Canada, US, EU) GMP Drug Audits conducted over 60 global Inspection preparation & hosting during facilities. Over 12 Sterilization Facilities. government inspection (Health Canada & FDA); PAIs, Supplier, ISO Audits (ISO 13485:2003); Quality Mock FDA/HC audits; Consultant audits for HC Release of Drug Products; Validation submittal Documentation & Virtual Regulatory & Compliance Service Pharmacovigiliance Expert Opinions for law firms. GMP Training and Technical Trainingincluding Computer System Validation training. SOP GCP monitoring & Design Training Tool development
11 ERP Practice/ System Validations Integration/ IT Solutions Process Validations including sterilization, depyrogenation, sterile filling, compounding, packaging, cold-chain etc. ERP Implementations, Delivery and Post-Live Support for clients in various Industry Sectors Method Validations and verifications of compendial tests Computer System Validations: LIMS, SAP R3, MS NAV 2009 R2, JD Edwards, BAAN, System Integrations and Interfaces of ERP, Complaint Handling System, Pharma Process MES, LIMS and PCS Systems for variousControl System, Formula Control System, QAD, Manufacturing and Distributions Clients BizFlow etc.Equipment & Facility Validations: WFI & DI Software Solutions developed by AxSource forWater System, Compressed air, Filter Integrity, Distribution, Warehouse Management, Quality- Clean Room Technology, CIP/SIP etc. Compliance and Documentation Management for various Industry Sectors
12Our clients may be researchers, CROs, manufacturers, importers,distributors, laboratories, contract manufacturers, API manufacturers,logistics, law firms, trade associations, regulatory consulting group andtraining companies.We serve as a virtual regulatory provider for many companies.For full range of services, pleasevisit www.axsource.ca .Our offices are located in Milton, OntarioAxSource Consulting Inc.336 Bronte Street SouthSuite 224-225Milton, OntarioL9T 7W6(905) 854-6059