Pharmasolve provides a complete regulatory strategy service — guiding you through the maze of current legislation.

We can compile all international dossiers, make submissions and negotiate with authorities to ensure swift approval.

We can be your representatives at any oral hearings or meetings with authorities.

We offer an Expert Summary writing and review service.

We can prepare CTC and CTX applications for clinical trials.

We can prepare EDMFs and COS applications and make all COS submissions on your behalf.

We have particular expertise in the following areas:

• EU Mutual Recognition Procedure - both strategic development and actual submissions/approvals.
• EU abridged applications for generic products
• Complex abridged applications such as for herbal products, new drug delivery systems, products containing new excipients, new indications / dosage forms of drugs containing known active constituents.
• Respiratory medicinal products and devices.
• Review of in-licensing dossiers.
• All types of variations, including change of ownership, change of manufacturing sites and new indications.
• Regulatory due diligence
• Exploring novel approaches for European applications
• Review and/or introduction of internal regulatory procedures
• Regulatory compliance
  

Development Management

PharmaSolve can provide information and assistance to help you implement new areas of product development.

We can undertake assessment of your current development systems, structures and resources and make suggestions for improvement.

We will evaluate or prepare development plans and assess the project risk.

We can identify suitable development partners and raw material suppliers

What new areas of product development can we help you with?

• New therapeutic areas? - we can help you to evaluate the costs, resources and equipment needed.
• New markets? - we can advise on what additional development work is required, help you manage that work and take your product to licence approval in that new market.
• Intending to develop products further along the development pipeline than previously? - we can advise on how to do that and provide resources enabling you to move into new areas of technical development.
• First time into clinical phases? - we can carefully plan any clinical work (including protocol preparation, ethics committees and regulatory applications) and then identify and manage a suitable clinical research organisation.
• Developing more complex products? - we can advise on the programme of work required and manage that work for you.
• Setting up development partnerships? We can audit development and manufacturing groups, introduce new development protocols and work together with partners to ensure they are conducting work to the highest standards.
  

Project Management

We can provide as much or as little Project Management support as you need. A highly experienced Project Management Consultant will assess your requirements and propose a programme tailored to your requirements.

Your Project Manager will work with both in-house staff and other external Consultants to build an effective project team. Any specialist consultant needed can be identified from our network and be managed by your Project Manager.

Your Project Manager will be your main point of contact throughout and will be available to provide any information on the project you require. They will provide you with regular project plans, reports and Gantt charts tailored to your requirements.

PharmaSolve can also provide you with assistance in setting up a Project Management function in-house. We can put together suitable project management procedures and systems for your company.

Some of the benefits that a Project Manager can bring to your project are outlined below:

• Enables interactive communications among senior management and project team.
• Co-ordinates effective and efficient participation.
• Develops project plans, including estimates, work breakdown structures and schedules.
• Provides a mechanism for monitoring and tracking progress regarding schedule, budget and technical performance.
• Creates an infrastructure for managing the project team.
  

Training

The consultants at PharmaSolve are experienced in pulling together training packages and delivering that training to participants, both at conferences and within companies.

PharmaSolve will prepare tailor made training packages for your company. A representative will spend time with you to determine exactly what your training needs are and then create a training programme to fulfil those needs precisely. We will then come into your company and deliver that training to as many or as few participants as you wish. It is a cost effective way of training a number of people and ensures that the training is tailored specifically to your needs.

Some of the areas that we offer training in are outlined below. However, if your specific needs are not mentioned, please do not hesitate to contact us as we may still be able to help.

• The Common Technical Document
• CMC requirements for the EU dossier
• The SmPC and product labelling
• European regulatory procedures — Centralised and Decentralised Procedures
• Regulatory strategy — ensuring your product gets to all markets on time
• Variations — implementing the guidelines
• Pharmaceutical development for the EU
• Project Management systems and procedures