Our Consulting Services Support Your Product Throughout the Development Lifecycle

The current regulatory environment requires pharmaceutical companies to be pro-actively prepared and to constantly assess their products' benefit/risk profile. Recent mishaps in labelling and in adverse event reporting have caused harm to patients, confusion to health care providers, and significant financial loss to companies. When partnering with Pregistry, pharmaceutical companies receive world-class technical support and solutions that can be used to meet their medical, regulatory, safety, and marketing needs in the areas of pregnancy and lactation.

Our Specialized Areas of Pregnancy and Lactation Consulting Expertise:

Regulatory Responses and Presentations

  • Response to PRAC Rapporteurs’ questions
  • Signal detection strategies
  • Development and implementation of PV systems
  • Audit preparation/Inspection support
  • Preparation and support for FDA Advisory Committee meeting

Medical Writing and Publishing

  • Labeling documents (US and ROW)
  • REMS, RMP, PBRER, PSUR, DSUR, IB, PADER, Signal analyses
  • Clinical Overviews and Safety Summaries
  • Literature search and review
  • Briefing documents
  • Medical publications writing

Study Design and Execution

  • Supportive data needed for regulators to approve and license
  • Drug Utilization Study to understand compliance with Pregnancy Prevention Program
  • Survey Study to provide information on prescriber and patient awareness of risk minimization measures

Regulatory reporting
Pregistry offers the following upon identification of an adverse event:

  • Adverse event triage
  • Case management/Assessment of relatedness
  • Event reporting.

Pregistry's Proprietary Databases

  • Pregistry's Universal Pregnancy Exposure Registry
  • Pregistry's Database of Medications and Vaccines in Pregnancy and Lactation
  • Pregistry's expert reports on medications and medical conditions during pregnancy and lactation

Additional Consulting Services

  • Everything you need from pre-IND, proof of concept, approval, to post-approval and lifecycle
  • Design and execution of pre-clinical and clinical studies
  • Development of marketing and communication tools
  • Support in litigation cases

Contact us now to see how we can help you

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We needed to access a large number of pregnant women who use our marketed products in a short period of time. Pregistry used its huge social media presence to meet our needs. We continue this great partnership!

T.M., Vicepresident of Drug Safety and Pharmacovigilance at a global pharmaceutical company

Contact us now to see how we can help you

Contact us