OUR SERVICES
Our experienced network of expert consultants combines deep industry expertise with contemporary knowledge to help you craft compelling, compliant product messages in the health, beauty, and wellness sectors. We believe science and regulatory compliance should enhance your business, not hinder it—let us help you achieve both compliance and competitiveness.
Let Concordia Handle Your...
Toxicology
Integrated health hazard assessments • Toxicology safety and risk assessments • MoCRA compliance • Investigative toxicology • Technical data organization
Regulatory Affairs
Regulatory intelligence • OTC Monograph Reform (OMOR) • Policy interpretation and compliance • Strategy development • Health authority communication • Product registration and listings • Product claims
Medical Affairs
Clinical evidence generation and development strategies • Medical documentation review • Stakeholder engagement • Scientific publications • Scientific rationales
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Independent Review Board (IRB)
Specialized expertise in cosmetic and OTC research • Compliance with global standards • Risk mitigation for human studies • Transparency and consumer trust • Tailored support for novel claims
Rx-to-OTC Switch
and Direct-to-OTC Switch
Regulatory intelligence • Policy interpretation and compliance • Strategy development. Health authority communication • Product registration and listings • Product claims
Prescription, Consumer Healthcare, and Cosmetic Product Support
OMOR policy and interpretation • OTC monograph compliance • MoCRA • Citizen Petition • Product promotional claims • Product positioning • Life-cycle management • Foreign product introduction
Unlock Your Product’s Potential with Our Expert Consulting Services
Concordia Integrated Solutions offers customizable and individual programs for the most efficient and quality-focused deliverables. We specialize in providing comprehensive and integrated regulatory, medical, and safety consulting services for pharmaceutical and OTC drugs, dietary supplements, and cosmetic products.
Our extensive network of seasoned experts can assist you to ensure your products meet all necessary compliance standards, including OTC Monograph Order Requests (OMOR), monograph compliance, and product life-cycle management.
Products marketed ex-US can pose unique challenges to bring to the US – we have the experience to assess product formulations and labeling and determine how to bring them to the US market quickly and efficiently.
WHAT WE OFFER
Regulatory Compliance
Navigate the complex regulatory landscape with ease. We ensure your products comply with all relevant regulations and guidelines.
Medical Consulting
Leverage our medical expertise to ensure scientific accuracy and full representation of relevant and relatable product features, especially the safety and efficacy
Product Safety Services
Protect your brand and consumers with our robust safety assessment, health-hazard assessments, recall guidance and toxicology ingredient reviews.
Life-Cycle
Management
From product development to post-market surveillance, we support your product’s journey every step of the way.
Mergers and Acquisitions
Due diligence • Portfolio and product assessment • Risk evaluation and mitigation • Competitive landscape assessment • Brand/portfolio expansion opportunities
Comprehensive Integrated Services
Insights • Product positioning • Lifecycle management • Stakeholder identification • Trade association representation and consulting
Complex Problems
Custom Solutions
Let Concordia Integrated Solutions extend your staffing needs or provide expert consultation on expanding product pipelines, OTC drugs, Rx-to-OTC switch, Direct-to-OTC switch, NDA, cosmetics, dietary supplements/DSHEA, homeopathic drugs, MoCRA compliance, and OTC Monograph Reform.
By partnering with Concordia Integrated Solutions, you can focus on growing your business while we handle the complexities of regulatory and scientific requirements. Let us extend your staffing needs or provide expert consultation by partnering with us.
“All work is creative work if done by a thinking mind.”
— Ayn Rand