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RxMD is committed to providing high-end medical and scientific consulting to the pharmaceutical community.

For over 15 years, we have proven to be a trusted partner in the development journey of top rung global biopharmaceuticals. We support our clients throughout the development journey, so that effective and safe new products can reach patients.

About Us

Success in drug development requires navigation through contrarian pulls and pressures, while at the same time integrating the diverse expertise of various teams into a meaningful whole. Given its considerable expertise and experience in developing new products, RxMD is uniquely positioned to provide its clients with the edge in taking the correct decisions - at the correct time.

RxMD, since its inception, has striven to adhere to high scientific rigor, exacting standards of quality and scrupulous professional integrity, without compromising on timelines – in other words an unrelenting commitment to exceeding customer expectations.

RxMD’s scientific expertise has been a pivotal element in drug development programs of our clients both in the US and the EU. We have provided executive management consulting on various clinical programs in diverse therapeutic areas. These include successful filings of NDA's for influenza, hepatitis B and C, HIV, and erectile dysfunction.

In addition to other aspects of clinical drug development, RxMD has also consulted with companies on drug safety – including in the post-marketing stage. RxMD has made critical contributions to numerous drug safety projects, even serving as member of the sponsor’s core team at FDA advisory meets.

RxMD's peer-to-peer Scientific Medical Consulting Services straddle drug development, drug safety, data interpretation, and writing of documents on complex topics.

That RxMD has succeeded in living by its credo of not “letting down” the customer is evidenced by the formidable reputation it has garnered over the years, coming to be highly regarded in the pharmaceutical industry as a trusted and valued partner.


 

Evolution and
Key Milestones

Drug Development: 2000-
  Regulatory filings:
  NDAs – HCV, HBV, flu
  Pediatric bridging NDA - HIV
  IND – Genomics, HCV, cachexia

Document Writing: 2002-
Study design:
Small mol - Antiviral for preterm/term infant Rx, Huntington disease, parkinsonism, fascioscapulohumeral dystrophy

mAbs - IL17 antagonist for inflammation, VEGF inhibitor for AMD and DME, *zumab for urticaria

Cell and gene therapies - renal transplant, expanded umbilical cord blood

Document Writing: 2002-   Clinical study reports (CSR)
  Integrated Summary of Efficacy (ISE)
  Integrated Summary of Safety (ISS)
   Risk Management Plan (RMP)
   Periodic Safety Update Report (PSUR)
   Periodic Benefit Risk Evaluation Report (PBRER)
  Regulatory communications and highly cited manuscripts have been published based on our reports

Safety Assessments: 2007-   Aggregate events (see above PSUR, RMP, PBRER)
  Sub-groups-infants,pregnancy
  Situations - pandemic
  Drug-drug interactions
  Product contaminations
  Recent – Dx rescue, lawsuit