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About Us

In the heavily regulated pharmacovigilance industry it is challenging to meet the regulatory standards. With Holitas’ experts in place these challenges can be easily managed in order to meet the exacting specifications required.

The Managing Director, Miranda Tasko BSc., founded the company in November 2009.She has been in the pharmacovigilance industry since 1998 and has worked for a number of prestigious pharmaceutical companies, in both the innovative and contract research organisation (CRO) sectors.

She has acquired extensive experience and knowledge in a wide variety of pharmacovigilance services during her time in the industry, which includes the successful set-up and management of a pharmacovigilance department for a consultancy.

Holitas Limited provides a range of pharmaceutical development and project management services to support generic pharmaceutical development. 

Its expert in generic pharmaceutical development and project management has over 30 years industry experience and can manage and facilitate each step of your development project.

As well as providing project management expertise, Holitas can also offer audit and inspection services in respect of all cGMP activities and support in developing data generation and submission strategies.

The Holitas team has a combined experience of over 40 years in the pharmaceutical industry.

Holitas Limited provides the following extensive range of PV and Product Development Services.

Pharmocovigilance services

  • Adverse Drug Reaction Management
  • Electronic reporting to the Regulatory Authorities

  • Literature Searches
  • Pharmacovigilance Reports
  • Writing SOPs
  • Pharmacovigilance training

  • Pharmacovigilance audits
  • QPPV
  • Continuous review of safety data-Signal detection

Pharmaceutical Development

  • Project Management
  • Development Stategy
  • Nebulised product development

  • Sterile Ophthalmic product development
  • Metered dose inhalations development
  • Bioequivalence testing

  • Solid Dosage form development
  • Laboratory inspection and Audit

  • Manufacturing inspections and Audit (sterile and solid dosage form)

  • Extensive experience with EU and US (FDA) regulatory data generation and submission strategies
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