Through our collaborative approach and expertise Edge is proud to offer a comprehensive set of value-added activities and services.

Edge offers a unique and fresh approach to our product development cooperations, with a long-term commercial view. Our objectives ensure the robust development and reliable supply of products in order to add true value to patients and healthcare professionals.

Some of our core development activities include:

  • Strategic portfolio reviews
  • API selection
  • Patent reviews
  • Early stage lab-scale formulation work
  • Analytical method development
  • Technology transfer
  • Process validation
  • Stability testing
  • Clinical study design and CRO identification
  • Qualification and selection of finished product manufacturing sites
  • Scale-up and oversight on validation batch production
  • Dossier compilation

Our portfolio offers Edge the ability to design customised collaboration models to suit specific markets or our customer’s individual needs. We pride ourselves in our transparent and efficient communications that ensure all our cooperations are centred around agreements that are mutually beneficial and offer commercial growth potential to all parties.

Some of our core competencies which set Edge apart from our competitors include:

  • Extensive global network
  • Ability to leverage internal affiliate capabilities
  • Trusted strategic partner to many pharmaceutical companies
  • Proven record of delivering first-to-market opportunities
  • Focus on innovation
  • Strong portfolio development skills
  • Unique entrepreneurial approach
  • Interest in all B2B discussions
  • Flexibility to customize business models
  • License & supply agreements, exclusive distribution agreements, asset swaps, risk share agreements, co-developments, direct acquisitions, or any other practical commercial consideration.

Our experienced technical and regulatory teams take care of all forms of dossier preparations and submissions, as well as offering your business complete peace of mind across the product value chain from IP protection to life-cycle management and pharmacovigilance solutions – including IP protection, GMP audit and pre-audit preparations, validations, as well as close management and coordination of client specialists and technical staff.

Capabilities include activities such as:

  • Global regulatory competence with TGA, MHRA, EMA, and PIC/s countries HA
  • Pre-submission activities including dossier due diligence and regulatory submission strategy
  • Dossier compilations including cross-market gap analysis management and full dossier conversions to CTD / eCTD format
  • Marketing authorization applications and proven ability to navigate highly complex regulatory environments
  • Market leader in EXTEDO software applications
  • NCE experience
  • Medical device expertise
  • Post-marketing authorisation activities including maintenance, variations, renewals, notifications, public notifications as well pricing and reimbursement
  • Tender market applications and expedited approval pathways
  • Named-patient applications

At Edge, we place an emphasis on providing comprehensive customer support, at all phases of the product life cycle. Our range of services is designed to create value across all areas of quality assurance and pharmacovigilance through a close collaborative approach with our partners. We provide flexible solutions and continuous process improvements to enable an ongoing ability to meet the increasingly complex regulatory requirements.

Our collaborative approach in optimising available resources enables cost-effective service offerings such as:

  • Provision of RP for QA purposes
  • Provision of QP for pharmacovigilance services
  • Drafting and review of SOPs
  • Consultancy services
  • Adverse events support
  • Periodic safety update reports (PSURs)
  • Medical writing and expert report consulting
  • Internal system audits
  • Third party GMP audits
  • Training oversight and management consultations

Customer service supported by honest open communication is central to our ability to sustain close ongoing business relationships with our partners across the world. The increasingly competitive landscape, pricing pressures, and reduction of blockbuster generics coming off patent highlights the importance of our Supply Chain Management expertise and professionalism. We hold the legislated certifications of GMP compliance required for batch release of sterile and non-sterile products, as well as for imported medicinal products and medical devices into the markets we operate in.

We cover the following activities:

  • Pre-launch activities and strategy design
  • Marketing plan formulation and budget preparations
  • Demand planning & forecasting requirements
  • Artwork design and coordination
  • Launch management, analysis, and reporting (data-driven)
  • Manufacturing and capacity planning
  • Logistics and freight forwarding management
  • Financial controls
  • Batch testing and release activities
  • Warehousing Services
  • Serialisation implementation and supporting activities