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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 both top rung and start-up 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 integrating the diverse expertise of various teams into a meaningful whole. Given its considerable medical/clinical expertise, RxMD plays a pivotal role in this integration and the continued translation in drug development up to commercialization. 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 adhered to high scientific rigor, exacting standards of quality and scrupulous professional integrity, without compromising on timelines – an unrelenting commitment to exceeding customer expectations.

RxMD’s scientific expertise has been a pivotal element in drug development programs of our clients in the US and the EU. RxMD has provided executive management consulting on various clinical programs in diverse therapeutic areas. These include successful INDs for multiple small molecules, biologics and cell therapy (renal transplant, inborn errors of metabolism) and filings of NDA's (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 – Solid organ transplant,   Inborn errors, Genomics, HCV

  Study design – infants (flu),   FIH (Parkinsons), cell  therapy   (renal transplant), Ph IV -   mAbs (IL17, VEGF, IgE)

Document Writing: 2002-
  Clinical study reports (CSR)

  Integrated Summaries of   Efficacy (ISE), safety (ISE)

  Risk Management Plan (RMP)

  Periodic Safety Update Report   (PSUR)

  Periodic Benefit Risk   Evaluation Report (PBRER)

  Investigator's Brochure (IB)

  Briefing Book (EU scientific   advise, EoP II meeting)

Safety Assessments: 2007-   Aggregate reports (PSUR, RMP,   PBRER) across drug  classes   (small mol, mAbs) and   therapeutic areas (antiviral,   oncology, metabolism, anti-     inflammatory)

  Sub-groups - infants,   pregnancy (published articles)

  Situations - pandemic flu   (published articles)

  Drug-drug interactions

  Product contaminations

  Dx rescue, lawsuit

  Recent – response to partial   clinical hold, immunogenicity