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A successful preclinical program requires innovation, expertise, and flexibility.

Advancing a pharmaceutical or medical device takes the right expertise at the right time.

 

Experience

PharmaFacts fills your knowledge and experience gaps by providing an individual or team selected from our growing network of PharmaFacts Preclinical Consulting teamwork highly seasoned independent consultants.

Combined, our experts draw on hundreds of years of diverse biopharmaceutical experience in academic, corporate, and government environments across numerous therapeutic areas. Our seasoned consultants have significant program management experience, including preparation of all preclinical sections of regulatory submissions.

More about our specific areas of expertise here.

Collaboration

Our background ensures that PharmaFacts is uniquely positioned to manage or address your preclinical, regulatory, and quality assurance challenges by customizing our services to match your particular circumstances.

In a collective effort on the part of our consultants, our leadership, and you, together we create an efficient collaboration that moves your program forward. Whether you need an added resource to your internal team or you prefer a hands-off approach by letting us take the reins, our specialists are flexible and prepared to carry out your requests.

Strategy

PharmaFacts Regulations - Quality AssuranceEarly drug development often proceeds under make-it-or-break-it conditions. Every decision counts.

Your pharmaceutical drug is a valuable asset. Every decision matters. PharmaFacts provides innovative oversight and offers strategic insights to help ensure that your program thrives.

We can help you navigate your path toward IND status and collaborate with you on the preclinical studies that need to go on in parallel with the clinical program. As issues arise that require a deeper understanding of underlying mechanisms in the clinical phases, we can advise on the plan of action to come up with cause-effect to aid in risk-benefit analyses.

Proven Track Record

PharmaFacts independent consultants have worked with teams inside Big Pharma, as well as within CROs, academia, and regulatory agencies, to successfully advance pharmaceuticals to market. Our consultants have experience in the following areas:

PharmaFacts CARDIAC RISK-BENEFIT EVALUATIONSADME • Biochemistry • Cardiac toxicity • Cardiovascular pharmacology • Cell biology • ADME Biochemistry • Cardiac toxicity • Cardiovascular pharmacology • Cell biology • Chemistry • Chemical formulations • Chemical carcinogenesis • Competitive market intelligence • CMC • CNS • Dermatology • Discovery toxicology (predictive modeling, toxicogenomics, molecular biology) • Genetic toxicology • GxP (GLP, GMP, and GCP) • Hematology • Impurities • Immunology • Investigative toxicology • Hepatic toxicity • Literature searches • Molecular pharmacology (assay development and drug discovery) • Medical biochemistry • Metabolism • Molecular biology • Molecular toxicology • Neurology • Oncology • Opthamology • Osteology • Over-the-counter switches • Pharmacokinetics • Respiratory pharmacology • Project Management • Pulmonary • Quality Assurance • Reproductive toxicology • Renal pharmacology • Regulatory submissions • Safety pharmacology • Technical/Medical writing • Thrombosis • Toxicogenomics • Toxicologic pathology • Urology • and Vascular pharmacology.