PharmaSolve Consultancy Limited - Pharmaceutical Regulatory Procedures, Project Management

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We offer consultancy services to the pharmaceutical industry helping companies through pharmaceutical development to licensing and on to product support and compliance. We have specialist expertise in the areas of Regulatory Affairs, Development and Project Management and tailor made Training Programmes.

Regulatory Procedures

We have considerable expertise in most therapeutic areas of pharmaceutical regulatory procedures, specialising in the following fields :

  • EU regulatory procedures (Centralised, Decentralised [DCP], Mutual Recognition [MRP] and National)
  • Generic products
  • New drug products with established APIs
  • Novel drug delivery systems
  • Medical devices
  • Drug Master Files [ASMF]
  • CTD compilation
  • Managing complete submissions for MAAs
  • Preparation and sign of expert overviews: clinical, non-clinical and CMC (Quality Overall Summary)
  • Regulatory due diligence
  • Development of regulatory strategy
  • Evaluation and restructure of internal regulatory procedures including regulatory compliance and change control
  • Review of in-licensing dossiers
  • Evaluation of orphan drug status
  • Scientific advice meetings with agencies such as EMEA, UK MHRA and NL CBG
  • Variations

Pharmaceutical Development Management

PharmaSolve are able to help companies review their current pharmaceutical development management situation and introduce changes in order to

  • Evaluate new therapeutic areas
  • Enter new markets inside and outside the EU
  • Take the current pipeline of products further through the development process
  • Move projects successfully into the clinical phase
  • Assist in the forming of strategic development partnerships
  • Develop more complex, sophisticated, higher value products

Project Management Systems

Our experts can provide as much or as little project management as required to allow

  • Effective, interactive communications between departments
  • Coordination of projects facilitating efficient input at all levels
  • Accurate planning giving cost estimates, work schedules and resource management
  • Tracking and monitoring of progress against agreed milestones
  • Introduce project team structures adding real value to development

Regulatory Procedures, Project Management, Medical Device Directives Training

PharmaSolve’s consultants can prepare uniquely customised training for staff in your company in the following areas

  • eCTD
  • EU dossier CMC needs
  • Labelling, SmPC and readability requirements
  • Centralised and decentralised EU regulatory procedures
  • Strategic approaches to regulatory
  • Implementation of variations guidelines
  • Tailoring your pharmaceutical development for the EU
  • Introduction or refinement of project management systems
  • Medical Device Directives Training

Contacts

Dr Mandy Cooke or Brian Atkinson
20 Victoria Road
Woodhouse Eaves
Loughborough
Leicestershire
LE12 8RF
UK

Tel: +44 1509 890990
Fax: +44 1509 890992

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