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Preclinical GPS - Global Preclinical Services | Preclinical Consulting | Non-clinical and CMC Programs

Preclinical GPS – Global Preclinical Services provides preclinical consulting services including preclinical and CMC (Chemistry Manufacturing and Controls) programs. We provide expertise and consulting on pharmacology and toxicology.

http://www.preclinicalgps.com/

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CONTACTS AT PRECLINICALGPS.COM

Preclinical Safety Consulting

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Preclinical Safety Consulting

Peter Korytko

9776 NE ●●●●●●●●chool Rd

Bainbr●●●●●●Island , Washington, 98110

United States

206●●●913
ko●●●●●●●●●●●●●●@gmail.com

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Preclinical GPS - Global Preclinical Services | Preclinical Consulting | Non-clinical and CMC Programs | preclinicalgps.com Reviews
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Preclinical GPS – Global Preclinical Services provides preclinical consulting services including preclinical and CMC (Chemistry Manufacturing and Controls) programs. We provide expertise and consulting on pharmacology and toxicology.
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Preclinical GPS - Global Preclinical Services | Preclinical Consulting | Non-clinical and CMC Programs | preclinicalgps.com Reviews

https://preclinicalgps.com

Preclinical GPS – Global Preclinical Services provides preclinical consulting services including preclinical and CMC (Chemistry Manufacturing and Controls) programs. We provide expertise and consulting on pharmacology and toxicology.

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1

Regulatory | Preclinical GPS – Global Preclinical Services | Writing Non-clinical Regulatory Documents

http://www.preclinicalgps.com/scientific-services/regulatory

CMC & Formulations. CMC & Formulations. Writing non-clinical regulatory documents. We also author the following sections for IBs, INDs, NDA, CTA, and BLAs:. Guidance to clinical investigators. We ensure appropriate compliance with GLPs, OECD guidance, and ICH guidance, as well as regulatory requirements for global regions. Preclinical GPS also represents you and your program during interactions with the FDA, Health Canada, and EMA, as well as other regional regulatory agencies.

2

CMC & Formulations | Preclinical GPS – Global Preclinical Services | Managing Formulations and Manufacturing

http://www.preclinicalgps.com/scientific-services/cmc-formulations

CMC & Formulations. CMC & Formulations. CMC & Formulations. Effective non-clinical drug development programs rely on appropriate formulations and reliable CMC for manufacturing for drug supply. Formulations – Start early and get it right. Having an appropriate formulation for non-clinical and clinical development is essential for smooth drug development. Preclinical GPS can help get formulation development completed early so that the transition from non-clinical to clinical development is seamless.

3

Pharmacokinetics/ADME | Preclinical GPS – Global Preclinical Services | Customized PK and ADME Plans

http://www.preclinicalgps.com/scientific-services/pharmacokinetics-adme

CMC & Formulations. CMC & Formulations. Pharmacokinetics studies assess the body’s effect on the drug. Typically, this includes measurement of absorption, metabolism, excretion, and distribution, as well as systemic exposure. Customized pharmacokinetics and ADME programs. Preclinical GPS customizes PK and ADME plans for each drug and program. This customization takes into account the following:. Modality of your drug (small molecule, antibody, peptide, oligonucleotide, or other). Stage of drug development.

4

How We Work | Preclinical GPS – Global Preclinical Services | Partnering With Clients

http://www.preclinicalgps.com/how-we-work

CMC & Formulations. We partner with clients in 3 ways. Hourly: We work on an hourly rate on a limited basis for work that we do not control (pre-IND meetings, review sessions, ad hoc consultation). For limited select projects, we are sometimes willing to serve in exchange for shares of the company. We believe that it is unfair to customers for consultants to control the price per hour and the number of hours worked; this leaves the clients wondering (and nervous) about the final bill.

5

Who We Are | Preclinical GPS – Global Preclinical Services | Peter Korytko and Associates

http://www.preclinicalgps.com/who-we-are

CMC & Formulations. Preclinical GPS LLC was originally formed as Preclinical Safety Consulting. The name of the company was changed to Preclinical GPS – Global Preclinical Services LLC with the expansion of services beyond preclinical safety and the opening of company offices and affiliates in the US, Canada, and India. Peter Korytko, PhD, MBA.

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