Pharmaceuticals
Guiding drug development from lab to market with precision and regulatory compliance.
Title 21 CFR § 211
Driving Transformation Through Expert Consulting & Strategic Solutions
We help you navigate complexity, accelerate market entry, and drive measurable growth with precision and expertise.
Industries We Serve
Tailored expertise for every industry
Medical Devices
Ensuring safety, quality, and efficiency in every device through end-to-end regulatory support.
Title 21 CFR § 820 & ISO 13485
Food & Supplements
Helping you navigate complex regulations to deliver safe, compliant, and trusted consumer products.
Title 21 CFR § 111 & 117
About Us
At ChiMera Services, we understand that navigating the complexities of regulatory compliance and product development isn’t just about meeting standards, it’s about achieving business success and driving innovation.
With 20 years of expertise across pharmaceuticals, medical devices, and food/supplements we partner to tackle the unique challenges you face.
We work closely with your team to address the unique complexities of your business, whether you’re in the early stages of product development or preparing for market realization.
Our teams are based in Central Oregon and the Great Lakes region of the Midwest, allowing us to support clients nationwide with agile, hands-on service.
Our Expertise
Transforming Challenges into Strategic Solutions
We help pharmaceutical companies accelerate their product journey with end-to-end regulatory compliance, API development, and process validation. Our expertise spans from early-stage development to market realization, ensuring each step is aligned with global regulatory standards.
- Regulatory Compliance & Product Development: Streamlined compliance with FDA regulations, GMP guidelines, and quality assurance.
- Analytical Testing & Quality Control: Ensuring rigorous quality standards with advanced analytical chemistry and testing.
- FDA Support & Form 483 Response: Priority response for FDA citations and warning letter
We optimize medical device development through regulatory guidance, process optimization, and risk management. Our services ensure your devices are compliant, efficient, and ready for FDA approval.
- Regulatory Guidance & Process Validation: Navigate FDA, CE, and global regulations with streamlined compliance.
- Risk Management: Identify and mitigate risks early, ensuring safety and efficiency.
- FDA Citations & Warning Letters: Expert support for Form 483 responses and corrective actions.
From product testing to regulatory compliance, Chi Mera Services ensures your food and supplement products are safe and market-ready. We help navigate FDA regulations, maintain GMP compliance, and ensure consumer trust through rigorous testing and validation.
- GMP Compliance & Product Testing: Ensure full FDA compliance and safety validation.
- Regulatory Support: Navigate complex FDA and global regulations for safe product launch.
Why Choose Us?
Strategic Expertise. Tailored Solutions. Proven Impact.
We help pharmaceutical companies accelerate their product journey with end-to-end regulatory compliance, API development, and process validation. Our expertise spans from early-stage development to market realization, ensuring each step is aligned with global regulatory standards.
Industry Leadership:
Decades of experience in pharmaceuticals, medical devices, and food/supplements, delivering measurable results.
Comprehensive Support:
From quality management system implementation to regulatory audits, we guide every phase of your product lifecycle.
Tailored Solutions:
Every project is customized to meet your specific needs, driving strategic growth.
Proactive Risk Management:
Mitigate risks, reduce delays, and ensure smooth operations.
Regulatory Mastery:
Navigate complex FDA, GMP, and global regulations with confidence, minimizing risks and ensuring compliance.
Nationwide Expertise
We deliver expert consulting across the U.S., helping businesses meet regulatory standards and accelerate product realization, regardless of location.
Our Reach Spans the U.S.
- East Coast
- West Coast
- Midwest
- South
- Northwest
Get In Touch
How Can We Help You?
Ready to streamline your path to success? Whether you’re developing a new product or navigating complex regulatory hurdles, we’re here to help.