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Strategic Regulatory Consulting | Drug Regulatory Affairs Consulting, Medical Writing, FDA Submissions, and Preclinical Toxicology

SRC has a proven track record in drug, medical device, regulatory consulting and medical writing. Our highly experienced regulatory consultants bring a wealth of knowledge of the most up-to-date regulations, directives, laws, policies, and guidelines. Our medical writing expertise spans most therapeutic areas. We are competitive, honest, and realistic.

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Strategic Regulatory Consulting | Drug Regulatory Affairs Consulting, Medical Writing, FDA Submissions, and Preclinical Toxicology | srcteam.com Reviews

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SRC has a proven track record in drug, medical device, regulatory consulting and medical writing. Our highly experienced regulatory consultants bring a wealth of knowledge of the most up-to-date regulations, directives, laws, policies, and guidelines. Our medical writing expertise spans most therapeutic areas. We are competitive, honest, and realistic.

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3 regulatory consulting

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5 toxicology

6 preclinical toxicology consulting

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Strategic Regulatory Consulting | Drug Regulatory Affairs Consulting, Medical Writing, FDA Submissions, and Preclinical Toxicology | srcteam.com Reviews

https://srcteam.com

SRC has a proven track record in drug, medical device, regulatory consulting and medical writing. Our highly experienced regulatory consultants bring a wealth of knowledge of the most up-to-date regulations, directives, laws, policies, and guidelines. Our medical writing expertise spans most therapeutic areas. We are competitive, honest, and realistic.

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Services & Capabilities | Strategic Regulatory Consulting | Toxicology Consulting

http://srcteam.com/services

Safety & Toxicology. OSHA & EPA. Azar M. Hazrati. We Provide Solutions…. Drug and Medical Device Regulatory Consulting. Preclinical Safety and Toxicological Risk Assessment. Drug and Medical Device Manufacturing Consulting. OSHA and EPA Compliance. Medical Writing and Regulatory Submissions to FDA. We have been in the medical writing, preclinical toxicology and regulatory consulting business for many years, with most of our work coming from repeat business and happy referrals. OSHA and EPA Compliance.

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Medical Writing & Regulatory Consulting | Strategic Regulatory Consulting | Regulatory FDA Submissions

http://srcteam.com/services/medical-writing-and-regulatory-submissions

Safety & Toxicology. OSHA & EPA. Azar M. Hazrati. Our experienced writing team provides. Quality documents on time! Medical Writing and Regulatory Submissions. Medical Writing and Regulatory Submissions. Our medical writing and regulatory submission services include:. Drug submissions: IND, NDA, CTD, ANDAs. Medical Device submissions: 510(k), IDE, PMA. Investigator’s Brochures and Briefing Documents. Clinical Trial Documentation: Protocols, Informed Consent Forms, and ICH-compliant Clinical Study Reports.

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Drug CMC & Medical Device Manufacturing Compliance | Strategic Regulatory Consulting |

http://srcteam.com/services/drug-cmc-medical-device-manufacturing-compliance

Safety & Toxicology. OSHA & EPA. Azar M. Hazrati. We provide solutions that save you time and money…. Drug CMC and Medical Device Manufacturing Compliance. Drug CMC and Medical Device Manufacturing Compliance. Our drug CMC and medical device manufacturing compliance support services include:. Review and assessment of drug CMC plans. Define requirements for analytical methods, process development, specifications, and stability studies. Audits for GMP compliance. Preclinical Safety and Toxicology. 2011 Str...

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Reference Library | Strategic Regulatory Consulting | Toxicology Consulting

http://srcteam.com/library

Safety & Toxicology. OSHA & EPA. Azar M. Hazrati. Reference Library and Useful Links. Reference Library & Useful Links. The mission of BioOhio is to accelerate bioscience discovery, innovation, and commercialization of global value, driving economic growth and improved quality of life in Ohio. BioOhio, founded in 1987 as Edison BioTechnology Center and formerly Omeris, is. Global RPh (searchable reference). Clinicians ultimate reference. Search Medical Terminology, Dosing, Drug Tables, Lab Values, etc.

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Zeinab Schwen | Strategic Regulatory Consulting | US FDA Consultants

http://srcteam.com/our-experts/zeinab-schwen

Safety & Toxicology. OSHA & EPA. Azar M. Hazrati. Let our experts support your team. President and Director of Medical Communications/Clinical Trial Support. Ms Schwen also brings to SRC her clinical trial management experience that she gained during her 10 years of employment at Marion Merrell Dow and later in her own company. Azar M. Hazrati. Subscribe to Our Newsletter. 2011 Strategic Regulatory Consulting. Regulatory and Preclinical Toxicology Consulting and Medical Writing Expertise.

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tera.org

TERA Pharmaceutical Support

http://www.tera.org/pharma

TERA is a world leader in deriving safe dose estimates for human health. What's the next step? To get more information about TERA’s pharmaceutical services or to talk to someone about how TERA can help you, please call us at: 513-542-7475. Or send an email to: TERA@TERA.org. Occupational Exposure Limits (OEL) and Workplace Risk Assessment. Occupational Exposure Limits (OEL) Development. Health and Safety Clearance of Chemicals. Product Quality Limits for Small and Large Molecules and Medical Devices.

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Safety & Toxicology. OSHA & EPA. Azar M. Hazrati. Whether you are a startup or a large multinational company, you can benefit from the experience and expertise of SRC to meet your objectives in a highly cost effective way. SRC has a proven track record in drug, medical device, and regulatory consulting. Also, SRC has been providing quality medical writing since 1987. We’ll find the most practical solutions to meet and accomplish your objectives. 8220;Their team has provided consistent, high quality and c...

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