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CMC Services Company: Chemistry, Manufacturing Controls Services Premier Consulting’s regulatory affairs and technical services experts have managed numerous product development and manufacturing programs for small molecules and biologics, which have culminated in the successful submission of CMC dossiers for investigational new drugs, clinical trial applications, biologics license applications, and new drug applications Recognizing that early
Agnieszka Marcinowicz - Premier Consulting Agnieszka also works closely with Premier’s regulatory experts to write and submit PK reports and clinical study protocols and reports
Fast-Tracking Hope: Early-Stage Planning For Rare Disease Drug . . . A multidisciplinary team, including clinicians, pharmacologists, and regulatory experts, is essential to successfully navigating these hurdles The FDA has recognized the challenges faced by sponsors and has launched several initiatives to support drug development for rare diseases
Our Approach - Premier Consulting Our product development and regulatory experts are relentlessly thorough, constantly asking why (and why not), taking nothing at face value, and being flexible enough to pivot and regroup when circumstances demand
PREA and Fixed-Dose Combinations: When Things Get Complicated In Premier Consulting’s extensive experience with pediatric plans, interactions with the FDA — especially those led by regulatory experts — are key to fully understanding the best path to follow while developing products intended to be marketed in the U S Establishing requirements for pediatric studies early in a development program
Greg Meyer - Premier Consulting Greg has been in the pharma, biopharma and medical device industry for over 30 years and has gained regulatory approvals in more than 20 countries He has represented companies during numerous interactions with the FDA, European national and EU regulators, and the Australian TGA and has worked on the development, submission, and commercialization of NMEs and 505 (b) (2) products in oncology
Tiffany Dorotheo - Premier Consulting Tiffany Dorotheo, Associate Director, Regulatory Operations, has in-depth experience preparing regulatory submissions to the Food and Drug Administration and other Health Authorities She supports early to late-stage development and complex submissions made to INDs, NDAs, BLAs, CTAs, NDSs, MAAs, and Master Files She also has experience maintaining and upgrading systems and procedures