Pharmacovigilance / Drug Safety:

  • Standard Operating Procedures, Work Instructions and Guidance Assistance
  • Review and Inspection Support
  • Evolving and Implementing CAPAs

Pharmacovigilance / Drug Safety:

In the present pharmaceutical, biopharmaceutical and medical device product scene, you can't bear to miss crucial safety data about your products. From preclinical studies to post-marketing settings, Genostats has the wide based involvement to provide complete clinical and post-marketed drug safety and pharmacovigilance counseling administrations to helps you to address product safety worries in a sure, proactive way. Our pharmacovigilance administrations begin with education. With our face to face and web based instructional classes, you can take in the intricate details of drug safety compliance. We will likewise help you in guaranteeing that your pharmacovigilance activities stick to the most recent US and EU laws, regulations, and direction. Any issues with pharmacovigilance consistence will be recognized and tended to with the urgency that is required in your field. In the event that you have drug safety and pharmacovigilance questions, our specialists anticipate your call.

The learning you will gain through our drug safety and pharmacovigilance services can help your organization in successfully presenting and keeping products available on market. Moreover, you can execute the correct methods that will enable you to avoid civil and criminal indictments by consumers and governments. Trust our group to give you with expert drug safety and pharmacovigilance consulting. Our strengths incorporate auditing, signaling, optimization, PV training, and European pharmacovigilance consistence.

Our Employees are well experienced in using ARUGUS SAFETY DATABASE and SAPPHIRE GLOBAL SAFETY DATABASE

A pharmacovigilance and drug safety from Genostats goes about as an immediate expansion of your team to help with:

  •   Standard Operating Procedures, Work Instructions and Guidance Assistance
  •   Review and Inspection Support
  •   Training and Consultancy
  •   Evolving and Implementing CAPAs
  •   Regulatory Safety Assistance
  •   Master Clinician Panel Support
  •   Restorative Information
  •   Pharmacovigilance System Master File Preparation
  •   Pharmacovigilance Database Consulting
  •   Turnkey Projects in Pharmacovigilance

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Medical Writing

Our comprehensive records are peer reviewed and experience a stringent quality assurance to guarantee medical and scientific accuracy.

Regulatory Affairs

The pharmaceutical business is regulated vigorously globally and is continually challenged by regularly advancing stringent directions.

Validations

The pharmaceutical business is regulated vigorously globally and is continually challenged by regularly advancing stringent directions, and the need to guarantee compliance. Genostats work closely to help our clients in the Pharmaceutical and life science.

CDISC Advantages

CDISC is the most significant advancement for convenience in data trade without perplexity inside the pharmaceutical business and between the industry and regulatory authorities.

Clinical Data Management

. Clinical Data Management We comprehend that high-quality data is significant for the achievement or failure of the clinical trial. Genostats provides Clinical Data Management service.

CLINICAL STAFFING

In the clinical industry, it takes many years and an extraordinary investment to bring a product to license.