Confidence in Safety Reporting and Regulatory Compliance
We specialize in setting up and running regularly-scheduled and well-structured literature searches for pharmaceuticals, biologics and medical devices, helping clients fulfill their regulatory requirements and stay informed on the safety of the product. As a dedicated literature search firm, this is our focused specialty so you can depend on the search results with the utmost confidence.
Pharma-Bio-Med Literature Search Services, a division of TPR International, Inc.
Literature Searching is our focused specialty, which means you:
- Minimize risk by knowing the literature search strategy has been developed correctly
- Have confidence for your regulatory reporting
- Can use internal resources elsewhere, knowing that your outsourced literature searches are taken care of
Literature Search Services
Scheduled Monitoring and Reporting
- New Drug Application (NDA)
- Periodic Safety Update Report (PSUR)
- Periodic Benefit Risk Evaluation Reports (PBRER)
- Development Safety Update Report (DSUR)
- Biologics License Application (BLA)
- Comparative Effectiveness Research (CER)
- Periodic Adverse Drug Experience Report (PADER)
- Other regulatory/PV related monitoring
- Clinical Evaluation Reports (CER)
- Safety signals
- Adverse events
- Systematic review
- Animal Health
- SOP documents
- Surveillance (alerts)
- Local literature searching
Why Pharma-Bio-Med for Regulatory Searches?
We are a dedicated literature search firm. This means that searching is our focused specialty so you can depend on the information we find to fulfill your critical safety and regulatory obligations.
In this competitive and highly regulated industry, information is both your greatest asset and your greatest challenge. You can depend on us; a search group that understands your industry from the inside, to deliver trusted information for your objectives.
Quite simply, with Pharma-Bio-Med Literature Search Services you receive high quality, dependable literature searches along with excellent customer service. We thrive on going the extra mile for our clients each and every time.
Trusted Literature Search Experts each with 15+ Years Experience
- Top-of-their field information scientists, each with 15+ years hands-on search experience at leading biotech, pharmaceutical and medical device companies
- Strong knowledge of worldwide safety reporting requirements
- Corporate background, having worked as professional searchers within top R&D corporations at the forefront of the drug and medical device industries
- Profound expertise in cutting-edge search tools, databases and resources
- Honors and Awards from industry institutions
- Track record of successful outcomes
For over two-decades a number of the Fortune 100 have relied upon us for trusted literature searching. In addition to large corporations, we also support small to medium size companies. In-house teams outsource searching to us based on a reputation of trust, a quality work product and excellent customer service.
“In addition to delivering both quality and timely results, thank you for helping to educate me on the search strategy (how it was developed and how it works).”
Global Safety and Pharmacovigilance, Pharmaceutical Company
Client Success Story
A Fully-Integrated Literature Search Solution
A household name in pharmaceuticals was seeking additional support from an external partner to help meet their literature searching commitments for their regulatory and pharmacovigilance (PV) reports. They were looking for a proven and experienced literature search team that could hit the ground running and perform thorough literature searches on an ongoing basis for all of their NDAs, DSURs, PSURs, etc.
The searchers for this outsourced work needed to be expert in scientific literature searching, possess a deep knowledge of the coverage and complexities of different literature databases, and have prior experience in having conducted these specific types of searches for a pharmaceutical company. A key factor was the absolute need to be able to provide continuous coverage in order to meet the specific, ongoing deadlines for the searches to be run, including managing and monitoring regular alerts. While there was an internal point of contact at the client company, the outsourcing partner needed to be pro-active to monitor the search load and ensure delivery of results on time without exception.
Pharma-Bio-Med met all the criteria. The team was able to work seamlessly with the internal processes already established to act as an extension of the company’s own internal department.
The relationship resembled a well-oiled machine. The SOPs already in place were reviewed by the Pharma-Bio-Med team and further refined as needed, and new SOPs were developed and documented as necessary. Pharma-Bio-Med quickly became a trusted partner in helping the client to meet their regulatory and PV obligations.
This successful relationship led to Pharma-Bio-Med being asked to provide support to other parts of the organization, including Medical Affairs, Competitive Intelligence and other business groups.