Meridan Consulting specializes in consulting services for the pharmaceutical industry. This New Jersey-based company was founded in 2001 by Elyse Smith, a former FDA Consumer Safety Officer (Investigator) from the New Jersey District. The company consists of over 50 consultants, many of whom are former FDA Investigators, all of whom were individually selected by Elyse based on experience and area of expertise.
The company was founded with the goal of helping companies to “Always Be Inspection Ready”. Since its inception the company’s focus has been on assisting firms to obtain FDA site approval and maintain compliance throughout new product introductions. Meridan represents clients to FDA and has a long-standing history of helping companies to successfully respond to FDA-483 observations, Warning Letters and Notices of Import Alert.
Our pharmaceutical consultants have experience ranging from product development to regulatory affairs. Our team is uniquely qualified to assess your company’s facility, file your product applications and provide specific direction that promotes a successful inspection outcome. We not only identify potential areas of concern, but also provide specific advice on how to remediate. Meridan Consulting has a proven track record when it comes to helping firms obtain an acceptable FDA compliance profile and product approvals.
Meridan Consulting is certified as a Women’s Business Enterprise by the Women’s Business Enterprise National Council (WBENC), the nation’s largest third-party certifier of businesses owned and operated by women in the U.S.
Company Details
- Employees
- 11
- Founded
- -
- Address
- 300 Carnegie Center Drive,
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- meridanconsulting.com
- Keywords
- Audits and Assessments, Quality System Development, Registered US Agent, Training Program and Content Development, Auditor Certification, Investigator Certification, Microbiology, Analytical Chemistry, Sterile Injectibles, Project Management, Data Integrity, 483 Support, Warning Letter Support, Import Alert Support.
- HQ
- Princeton, NJ
- Competitors
- QualityHub, Essential Quality Solutions, Inc., AIICR | Advanced International Institute of Clinical Research, Gatik Surgical Industries Private Limited, BushmanQC Virtual QMS LLC, Qualtec Consulting, Exemed Pharmaceuticals, INOPHAR Consulting & Training, DP GxP Consulting, INOVR® - A Learning Experience that Counts!.
Meridan Consulting Questions
Meridan Consulting's website is meridanconsulting.com
Meridan Consulting's LinkedIn profile is https://www.linkedin.com/company/meridan-consulting
Meridan Consulting has
11 employees.
View email and phone details for 11
employees at Meridan Consulting.
Meridan Consulting's industry is
Pharmaceutical Manufacturing
Meridan Consulting's top competitors are
Qualityhub,
Essential Quality Solutions, Inc.,
Aiicr | Advanced International Institute Of Clinical Research,
Gatik Surgical Industries Private Limited,
Bushmanqc Virtual Qms Llc,
Qualtec Consulting,
Exemed Pharmaceuticals,
Inophar Consulting & Training,
Dp Gxp Consulting,
Inovr® - A Learning Experience That Counts!.
Meridan Consulting's categories are Pharmaceutical Manufacturing
Meridan Consulting's founding year is 2001
