Unlimited Colors

Magic Cursor

home-profile

CONNECT With

Paracelsus Consulting

Professional Services

The comprehensive nonclinical safety testing program required to support clinical development and ultimate registration of a novel therapeutic involves years of work and many different types of studies. This nonclinical safety program - which begins prior to initiation of clinical trials and often continues after a drug is approved for marketing - is an essential component of the pharmaceutical R&D process and represents a considerable financial investment to the innovator.

As CEO/President of Paracelsus, Inc., Grace M. Furman, PhD has been providing professional nonclinical safety services to the pharmaceutical industry as board-certified independent toxicology consultant since 2007.   

Introduction

About Us

my picture
Good Day We are

a Proficient design and support of nonclinical testing programs requires a customized and integrative strategy that is relevant to the intended clinical indication and acceptable to global health authorities.

BParacelsus can help your organization successfully meet this challenge by offering a range of professional consulting services. Discipline-specific expertise in key areas such as toxicology, veterinary pathology, pharmacology and pharmacokinetics is available to Paracelsus clients through highly knowledgeable and experienced professionals.

Willow Toxicology information

  • Referral Contact: Mark Osier
  • address : 13520 Evening Creek Dr. N. Suite 100
  • City : San Diego, CA 92128

Professional Services We offer to our clients

Paracelsus Services

Paracelsus can help your organization successfully meet this challenge by offering a range of professional consulting services.
Discipline-specific expertise in key areas such as toxicology, veterinary pathology, pharmacology and pharmacokinetics is available to Paracelsus clients through highly knowledgeable and experienced professionals.

Nonclinical Services

Discipline-specific expertise in key aspects of small molecule nonclinical safety is available to Paracelsus clients through highly knowledgeable and experienced professionals. Expertise is available in the following areas:
• Toxicology
  o General toxicology
•All Species •All routes of administration
o Genetic toxicology
o Developmental and Reproductive Toxicology
• Safety Pharmacology
• Small molecule oncology [ICH S9] and non-oncology [ICH M3] development programs
• 505(b)(1) and 505(b)(2) US registration strategies
• Efficient nonclinical safety strategies supporting selection and advancement of molecules at all key stages (i.e., discovery through post-marketing)
• Experienced nonclinical safety representation during formal meetings with Global Health Authorities (US and ex-US).

Regulatory/Submission-Level Document Preparation and Review

Paracelsus professionals deliver timely, high-quality nonclinical safety (toxicology and safety pharmacology) contributions to global regulatory submissions including Pre-IND Information Packages, INDs/CTAs, Periodic Regulatory Reports (e.g., DSURs), Investigator’s Brochures and global product labeling documents.

Due Diligence Projects

Critical review and assessment of nonclinical safety data from a drug developer or potential partner perspective.

Check out the latest Medicare News

Bridlewood News

Survey Finds Older Adults Have an Optimistic Outlook on Life; Expect Their Lives to Improve as They Get Older WASHINGTON—According to a new AARP survey exploring the second half of life, most older adults have an optimistic outlook on life and expect their lives to improve as they get older.

Medicare will now negotiate drug prices every year, thanks to the 2022 prescription drug law that AARP championed, benefitting millions of older Americans for years to come WASHINGTON—Today, AARP Executive Vice President and Chief Advocacy and Engagement Officer Nancy LeaMond issued the following statement in response to the Centers for Medicare & Medicaid Services (CMS)

WASHINGTON—AARP CEO Jo Ann Jenkins issued the following statement in response to the Medicare and Social Security Trustees Reports released today: “While there was good news today in the Trustees Reports, older Americans need certainty that Medicare and Social Security will be protected. For long term sustainability, Congress owes it to the American people to reach a bipartisan solution, ensuring people’s hard-earned Social Security benefits will be there in full for the decades ahead. The stakes are simply too high to do nothing.

We are Here Ready to Assist anytime

Contact Paracelsus Consulting

contact Agent

Our Contact Information

Paracelsus can help your organization successfully meet this challenge by offering a range of professional consulting services. We are here to Help!