Regulatory Insights

  1. Can Your Clinical Supply Chain Pass The Brexit Pressure Test?

    - Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask

  2. Twin Revolutions: Will New Tech Get Along With New Regulations In Clinical Research Technology?

    What can be done to that the technology opening new doors in the capture and analysis of clinical data, and the guidance responsible for regulating them, keep up with one another?

  3. Insights Into Medical Device Regulations From MAGI 2017 West

    Regulatory experts outline some of the regulatory changes on the horizon for the medical device industry.

  4. Japanese Sponsor Sources Partner For End-To-End Pharmacovigilance Case Processing

    Long-standing global relationship and history of quality important factors in selecting their partner to process foreign cases for PMDA submission for studies.

  5. Regulatory Change Is Coming in the EU – Will You Be Ready?

    As the global reach of clinical trials has increased, and with the deadline for EU compliance quickly arriving, many in pharma are finding themselves in a dilemma.

  6. Do THIS To Shorten Your Clinical Trial

    With sponsors facing increasing pressure to reduce drug prices and bring therapies to patients faster, follow these tips to shorten your clinical development process.

  7. 10 Things To Remember About The QP Role And Process

    The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.

  8. Top Brexit Questions Asked by Clinical Supply Professionals at the 2017 Sherpa Summer Seminar

    Based on their survey of San Diego's clinical supply community, there are a lot of concerns around Brexit's impact on clinical supply. Sherpa took the top questions asked by their Sherpa Summer Seminar audience, and answered them in this Q&A.

  9. Brexit Causing Uncertainty For Clinical Supply

    John Shillingford, Ph.D., Independent Consultant, communicates some concerns that sponsor companies should consider as they consider holding clinical trials in the EU or the UK in 2019 (when Brexit is scheduled to be official).

  10. A Wake-Up Call For APAC: FDA Requires Electronic Submissions By 2017

    The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.