Alacrity Pharma Associates

 

Contact Name: Alan Harris (Partner)

Tel: 07733314605

Website: www.alacritypa.co.uk

E-mail: alan. harris @ alacritypa. co. uk

Type of Organisation:  Consultancy Partnership

Business Sector: Pharmaceutical R&D

Profile:

Alacrity Pharma Associates was formed in 2010 to provide CMC support to small and virtual pharmaceutical R&D organisations. We provide a range of consultancy support for ongoing projects. We have also worked with some small CROs to assist them in developing their growth strategies and/or quality and HSE systems.

Products & Services:

We believe that the unique blend of extensive experience and capability we offer within Alacrity provides the expertise require to deliver development projects 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.
The list of services shown below is illustrative, but is not exhaustive;

Outsourcing of late stage Medicinal Chemistry and/or early phase development supply of drug substance and/or drug product

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

Outsourcing and Technology Transfer of late phase development and early commercial drug substance and drug product supply

  • 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.

Clinical Trial Supply

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

Due Diligence

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

Development of Business & Quality Systems

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

Auditing

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

CMC Regulatory

  • 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

Project Management

  • 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)
 

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