SERVICES

Licensing / Distribution Partnerships

  • Commercial access and geographic appearance with AFDOS extensive network in the UK/EU and African markets 
  • Identify and source finished products (with EU-GMP standards) through AFDOS from manufacturing sites in European and Asian territories

  • Distribution of partners’ products with/without its own brand.
Services
Services

Regulatory Affairs Consultancy

  • Registration strategies settings.
  • UK/EU & Africa region product registration: from preparation to approval.
  • Local MA maintenance.
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QUALITY MANAGEMENT

  • EU/UK GMP compliance audits
  • Mock and Pre-Approval Inspections
  • European batch release, importation and re-testing
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Services

Regulatory Affairs Consultancy

Our experts will guide your regulatory strategy to help you get the most from your products in the best possible timeframe, offering project management and support of your product development as well as registration. We can provide support in dossier preparation and registration, including co-ordination of scientific advice, product labelling preparation, along with continued support with lifecycle management including variations, renewal and transfer of marketing authorisations.

 

We assist with all your regulatory affairs requirements including:

  • Preparation of regulatory dossiers for the UK, Europe and other markets
  • Management of EU mutual recognition and decentralised licensing
  • Preparation of Quality Overall Summaries, Nonclinical and Clinical Overviews
  • Preparation or reformatting of DMFs into CTD format
  • Licence maintenance including variations, renewals and Change of Ownership applications
  • Advice on and preparation of SmPCs, labelling and leaflets
  • Reclassification applications
  • Liaison with Regulatory Authorities
  • Preparation of applications in e-CTD format’ and due diligence of dossiers

 

Our regulatory expertise can help optimise your development program and avoid unnecessary delays by:

  • advising on your development process, evaluate the risk-benefit profile, ensure the generation of the best data for your registration filing, and work with you to develop the optimal regulatory strategy to fit your requirements on timing, budget and markets of interest
  • helping you navigate through the relevant legislation, national guidelines and specific requirements to ensure regulatory compliance, providing regulatory advice for exploratory development programs and ensuring a smooth regulatory transition between the key phases of early development
  • helping you get the most from the scientific advice procedure with regulatory authorities

We have ample experience of all variation types, and can manage your procedure efficiently – whether it is an MRP/DCP, Centralised or a National procedure. We will guide you through the classification process and advise you on the most appropriate regulatory strategies.

We can also assist with post licensing activities, including:

  • regulatory compliance advice for any post licensing activity
  • reviewing and updating all documentation included in PBRERs, SmPCs and labelling
  • managing all regulatory authority communications for post licensing activities
  • provide strategic advice on regulatory requirements and submission routes for post licensing activities which can improve the financial outlook of your product
  • advising on appropriate variation filing strategy and ensure the appropriate supporting documentation are supplied

Other services include:

  • Risk management plans (RMPs)
  • Regulatory compliance projects
  • SOP preparation
  • Change of ownership
  • Sunset clause management
  • Review of advertising and educational materials
  • Referrals
  • DMF reviews
  • Article 61(3)
  • Technology transfer
  • Due diligence
  • Gap analysis

QUALITY MANAGEMENT SERVICES

We provide a leading edge strategic consultancy in Quality Management and offer a full complement of services from first entry, to market approval.

Our experts have many years experience of working with organisations in assessing and meeting their quality needs and understand that these needs change as products progress and businesses grow.

Areas of expertise include:

  • EU/UK GMP compliance audits
  • Mock and Pre-Approval Inspections
  • European batch release, importation and re-testing
  • Development and implementation of phase-appropriate quality management systems

We offer analysis, development planning and targeted portfolio services, offering you objective advice, improving your decision making, with advice on a sound quality system that can enhance your organisation through an iterative process of continuous improvement.