Regulatory affairs for compliance and success
Our team of regulatory experts guarantees full compliance with global and local regulations while perfectly crafting regulatory strategies for every step of product development – from manufacturing and processing to packaging and labeling.
We're experts in Chemistry, Manufacturing and Controls (CMC) management and submissions to regulatory bodies across the globe. With extensive experience in developing Common Technical Documents (CTDs), we can support you with successful regulatory presentations. Our expertise includes Module 3 development, the heart of the CTD, ensuring your product's formulation, analytical methods and manufacturing processes are watertight.
Global regulatory prowess
We have an impressive regulatory track record with validation from every inspection and have excelled in countless audits from the FDA, MHRA and EMA. We can provide you with the expertise to navigate the most intricate regulatory landscapes, offering strategic mastery throughout your product's journey.We’re your regulatory partner across:
- Over-the-counter (OTC)
- Rx therapeutics
- Rx-to-OTC switches
- Personal care and cosmetic pharmaceuticals
- Medical devices (Type 1 and Type 2)
Quality and compliance: Non-negotiable
Quality and compliance are at the forefront of everything we do. Our ongoing commitment to the highest standards, coupled with our robust quality management system and extensive quality expertise, empowers us to provide you with reliable and efficient regulatory solutions.
Overcome challenges and exceed regulatory expectations
When you partner with us, expect nothing short of regulatory excellence:
- Over two decades of impeccable regulatory experience
- An impressive track record of regulatory compliance
- Proven solutions for the most complex regulatory challenges
- A team of dedicated professionals with an in-depth understanding of global regulatory requirements
- An ongoing commitment to delivering high-quality, compliant products to the market
Frequently Asked Questions About Quality & Regulatory Affairs
Is Formulated Solutions FDA registered?
Formulated Solutions operates U.S. manufacturing facilities supporting FDA-regulated Rx, OTC, medical-device and cosmetic products and maintains an established regulatory inspection history.
What regulatory authorities have inspected or recognized Formulated Solutions?
Formulated Solutions has experience supporting products across multiple regulated markets. Current regulatory registrations, inspections and certifications should always be verified against the latest official Formulated Solutions information before publication.
What ISO certifications does Formulated Solutions maintain?
Verify the current certification list against the official website and current certificates immediately before publication. Relevant certifications have included quality, medical-device and cosmetic GMP standards.
How important are quality systems when choosing a CDMO?
Quality-system performance is one of the most important considerations because the CDMO becomes an extension of the sponsor’s regulated supply chain. Inspection history, investigation practices, data integrity, training, change control and batch-release systems should therefore be evaluated alongside cost and capacity.
Does Formulated Solutions have dedicated quality personnel?
Yes. Quality is a significant organizational function within Formulated Solutions. Verify any numerical percentage of personnel dedicated to quality against current company data before publication.
Can Formulated Solutions provide regulatory support?
Yes. Regulatory affairs is part of its integrated CDMO service offering, supporting appropriate Rx, OTC, medical-device and consumer-health programs.
Can Formulated Solutions review labels and claims?
Formulated Solutions’ regulatory capabilities can support appropriate label, ingredient and technical-documentation review depending upon the program.
Ever tried the Formulated Solutions approach?
Delivering excellence since 1999 from the forefront of innovation. Pushing boundaries and challenging the status quo underpinned by a bedrock of reliable quality. We're more than just a CDMO – we empower our clients to deliver impact with every action.