We develop and execute risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle.
Clinical & Pharmacovigilance Quality Systems
Vendor Oversight
PV Compliance
Growth Phase Compliance
Professional Development
Quality Systems Gap Assessment
Auditing
Mock Inspections
Quality Systems Documentation
Regulatory Advisement & Responses
Abbot Laboratories
Acorda Therapeutics
Alexion Pharma
Allergan
Amersham Health
Amgen
Ashfield Healthcare
Astellas Pharma
AstraZeneca
Baxter
Bedrock Group
BeiGene
BioForum, Ltd.
Biogen
Boehringer Ingelheim
Cedars-Sinai Medical Center
Celgene
ClinTrak
Cogstate
Collegium
Columbia University
Covance
Depomed
Daiichi Sankyo
DSG, Ltd.
Eisai
Eli Lilly
Esperion Therapeutics
Exl
Jefferson Healthcare
GE Healthcare
GlaxoSmithKline
Greenphire
Happy Medium
HITLAB
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IQVIA
IronMountain
Jazz Pharmaceuticals
Johnson & Johnson
Jubilant DraxImage
Labcorp
Lockwood Group
LSTI
Mallinckrodt Medical
Medpace
Mylan
NeoGenomics
Novartis
Ono Pharma
Otsuka
Pfizer
ProPharma
Puma
Regeneron Pharma
Rho
Roche
SanBio
Seattle Children's Hospital
Sloan-Kettering
Takeda
Tata
Temple University Healthcare
The Doctors Laboratory
ThermoFisher Scientific
Theradex Oncology
Theravance
Triad Isotopes
Tyco Heatthcare
Vigilare International
WCG Clinical
Valeant
Xendo
Wyeth
And more ...
We draw on our experience and insight to help pharma sector companies create and execute compliance strategies. With more than 25 years of pharma quality and compliance experience, we're uniquely qualified to fill several expanding, dovetailing industry gaps related to Clinical and PV Quality Systems, including vendor oversight.
We know the pharma industry inside and out, the drug development process start to finish, and the global regulatory requirements that impact your business. We understand the required strategic elements, how they should be prioritized and dovetailed, and how to execute for success. We're passionate about logic, creativity, and compliance. The industry needs more of all three and we're here to champion the cause.
What keeps you up at night? We pride ourselves in making the truth palatable, gaps actionable, and solutions practical. We partner with our clients to build relationships and positive outcomes while telling it like it is. Our expert advice and deliverables come sugar-coating free and filled with solutions. Don't know where to start or how to sort out what's already in motion? In either scenario, we can connect the dots and create a common sense strategy that supports life cycle compliance. Yes, so you can sleep at night ...
Give us a quick call any time. If possible, we'll chat on the spot or set up a time that works well. We look forward to hearing from you.
Prefer email? Reach out via email and we'll respond as soon as possible. We're happy to interact via email. We can always schedule a call if you'd like. As a rule, we don't make unsolicited calls to anyone. We know you're busy and so are we.
We focus on strategy, execution, and professional development within the Pharma/Biotech GCP and PV Quality Systems & Compliance space.
We develop tailored, intensive mentoring workshops unique to the industry focused on filling known industry-wide quality and compliance gaps.
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