Pre-Development

Pharmexon is able to advise on aspects of the development of a medicinal product or device at any stage of development. More notably, our clients would like “strategic inputs” even at target selection stage. This is important to note in order to understand the local and global pathway a development must follow. We are able to apply our experiences to identify possible pitfalls and common problem that can occur. Our experts are able to design preclinical and clinical strategies, synopsis and protocol. We provide appraisals of data/ideas as well as set-up and facilitate interaction with Agency committees.

Some of the services offered in this area are:
  • Clinical advice on “hybrid/505b2” developments of known APIs
  • Classification/advise on pathway for most medicinal product types
  • Regulatory/preclinical/clinical Strategy reports on new pharmaceutical forms/delivery systems/new administration routes/new dosages for purpose of business planning
  • Biosimilar advice for truncated programs according to current guidelines
  • Leveraging data from regional developments for global registration strategy and vise versa
  • Drug Device combinations
  • Advise on PK/BE strategy for standard and complex generics
  • Place predictors in place on Agency feedback on aspects of Quality, Clinical and Preclinical
  • Suggest truncation of programs based on other similar developments
  • Create briefing packages and facilitate meetings for Scientific Advice
  • Due Diligence of pre-development of formulations for CMC/Quality aspects - small and large molecules
  • Vaccine and biotech development challenges (ie process, upstreaming, program design)
  • Informal opinions from regulatory network
  • Map out the entire regulatory process, with possible timelines, including detailed Scientific Criteria for the product type (including GxP, manufacturing, documentation, clinical and preclinical programs)
  • Qualification of production of API and FP - GMP pre-audit of sites (API/GMP)

Development

During development, our clients face many challenges. The Pharmexon team is able to perform ongoing due diligence, as well as offer on-site support (if required) in order to assist in continued successful development. Additionally we are able to advise and support the appropriate strategy to begin and/or continue dialogue with Agency experts as part of a Scientific Advice program. Our experts are able to review a development from the perspective of regulators, and the wider network is able to provide inputs into practical elements of a development. Additionally, our team can provide advice on leveraging data being generated for a specific region and how a program can be truncated for another region.

Some of the services offered in this area are:
  • Due Diligence of CMC data during formulation development and scale-up
  • Due Diligence of Synopsis/protocol and reports of preclinical and clinical program
  • Ongoing support of development processes, analytical methods,raw material qualification, process controls
  • Review of preclinical data in order to present clinical program to regulators
  • Preparation and review of PK data for standard/complex generics
  • Preparation of Briefing Books including Question placement, data presentation, face-to-face representation and extrapolation of outcomes
  • On-site support and monitoring of clinical/nonclinical studies
  • Clinical trial applications - preparation and support
  • Critical support, reviews and data use between EU and US

Pre-submission

As part of the development support, we also assist our clients in all matters ranging from administrative all the way to complex scientific authoring for submission purposes. Additionally, all requirements, depending on the regions are advised upon well in-advance of a submission planning. Our team members were working in various roles in Agency and remain updated with regards to current and upcoming requirements, which is critical for submission planning.

Some of the services offered in this area are:
  • Strategic planning for MA submission - local and global
  • Authoring of Documentation for all Modules for CTD format
  • Consolidation of regulatory requirements per region to current standards
  • Gap Analysis and Dossier Compliance
  • Technical documentation preparation - ERA, RMP, overviews, summaries
  • Pre-auditing and prepare for GMP Inspection
  • Batch release and testing documentation
  • Local language requirements, documents and supports
  • Finalisation and review of full submission dossier
  • Publishing eCTD and versioning
  • Support for labelling and packaging material
  • Translations

Submission/Registration

As our team and associates were previously from Agencies, our expertise in submission and registration is a pivotal area. Apart from the regular services of submission in its simplest form, Pharmexon is able to provide ongoing strategy and inputs during the process. Our team understands that Agencies are made up of individuals and opinions can vary. Depending on the source of the query we can assist understanding the root cause of such deficiencies and assist in responding, negotiating or even deferring responses to the agencies. We can also assist in making decisions with regards to withdrawals or resubmissions, particularly in the light of transparency laws that currently exist. Our team is also experienced in leveraging other successful MA grants in other parts of the globe to assist in Agencies to make decisions in their own assessments.

Some of the services offered in this area are:
  • Fully compliant dossier submission in most regulated regions
  • Support(technical, administrative and regulatory) for Deficiency response and coordination
  • Facilitation of dialogue with Agencies during registration process
  • Support of finalisation of procedure/national phase
  • Management of referrals - regulatory and scientific
  • Troubleshoot/risk assessment of major concerns - strategy adaptation
  • Finalisation of critical texts for marketing purposes
  • Assistance in accepting/rejecting post-approval commitments
  • Assistance in GMP Inspections, CAPA and communication with Inspectors

Post-authorisation

Whether or not we assisted in the development and submission, we are able to provide standalone or ongoing services for post-approval maintenance. This can range from long-term support of all variations, renewals, PV and eCTD versioning through to a standalone submission of a change request to an Agency. We understand that this activity is a cost-burden to industry, yet is necessary as part of ongoing compliance. We are able to provide services in Life-cycle management that could minimise costs and meet critical timelines in order to ensure MAs are kept up-to-date.

Some of the services offered in this area are:
  • Variations, renewals, PSUR and eCTD lifecycle maintenance
  • Large volume variations, grouping for EU and minimise administrative burden for global submissions
  • Consolidation of renewals, preparation of dossier and submission
  • Pharmacovigilance activities
  • MA transfers and associated variations during acquisition transactions