We believe that the unique blend of extensive experience and capability on offer within Alacrity will provide the expertise you require to deliver your project to the required timelines, appropriate quality and optimal cost. Our breadth of knowledge enables us to offer consultancy support across the complete spectrum of drug development CMC related activities. We truly understand the necessary flexibility in interpreting international guidelines required at all stages in drug development. We aim to make this part of the complex drug development process as simple as possible for you and to equip you to deliver your project in a structured & and controlled way

The list of services shown below is illustrative but is not exhaustive; we are happy to discuss how we may be able to serve any of your needs. We provide advice in the following:

• Covering all aspects e.g. route selection, contractor selection, project management, process, analytical and formulation development, peripheral CMC data generation, etc

• Support for the development activities required to establish a robust commercial process meeting regulatory and supply requirements e.g. Technology transfer, risk assessment, and validation

• Support to design and operational delivery of clinical studies. This includes blinding and comparator strategies and outsourcing to CROs

• Assistance with due diligence e.g. strategies, preparation, and question responses

• Development of systems for the management of business and project risks e.g. quality system, control of costs and risk logs

• Provision of business orientated audits e.g. technical suitability, SHE, GMP compliance, and due diligence

• Provision of CMC support e.g. CMC sections of IND/IMPD, NDA, MAA documentation. This includes drafting, review and submission plus support with questions and Authority meetings

• Provision of direct project management support e.g. contactor management, business system integration, and complete CMC oversight (project plans, strategies, reports, risk logs and financial control)