Partnering with Innovators

OCALA PHARMS Rx Regulatory & Quality Assurance Experts

At Ocala Pharms, we focus on building strategic partnerships that drive the future of healthcare innovation forward.

Hand drawing Compliance flow chart concept on transparent wipe board isolated on white.

Test tubes, dropper and woman scientist in laboratory for medical study, research or experiment. Glass vials, pipette and professional female person with chemical liquid for pharmaceutical innovation

Elevate Your Biotech and Medical Device Compliance

Leverage our 30 years of industry expertise in Quality Assurance, Compliance, and Product Development to navigate the complex regulatory landscape with confidence. Our programs are designed to not only ensure adherence to FDA and ISO standards but also to boost your operational efficiency and market preparedness.

For foreign companies aspiring to enter the U.S. market, we are your trusted partner in navigating regulatory complexities and FDA relations, allowing you to focus on your core business activities while we handle compliance and certification challenges.

Identify critical issues with our proactive strategies
Experience seamless commercialization paths
Tailored solutions to empower your business
Explore our comprehensive services for operational excellence

Discover Our Services

Science, teamwork and scientist with tablet in laboratory for communication, pharmaceutical review or planning. Employees, collaboration and technology for research, discussion and digital analysis

ISO and GMP Compliance

OPRx will work with your organization to develop a comprehensive and defensible compliance system. We can also develop strategic commercialization programs.

EXPERTISE

New Product Commercialization (Medical Devices, MedTech, Biotech, Biologics, Pharmaceuticals)
Successful new business development, partnerships, and financial investments
Portfolio development and management across UK, India, Canada, APAC (JP, CN, KR, AU)
Technology assessment, development, and transfer across medical device & pharmaceutical businesses
Identification, creation, and implementation of new strategies for technology commercialization
Product development/commercialization budget responsibilities
Team leadership and interdepartmental management for product commercialization
Regulatory Affairs and Clinical Quality Assurance strategy, system, process, procedure execution
Lead auditor for vendor and partner management of contract research organizations (CRO and CDMOs)
QA oversight, batch manufacturing, validation activities, change management, GMP activities
Leading documentation reviews, GAP analyses, recommendations, and audits
Phase product development, business case development, go-no-go decision making expertise
Process optimization and continuous process improvement
Compliance with standards: 21 CFR Parts 211, 314, 600, 820, ICH E6(R2), EU 536/2014, ISO 9001, ISO 13485, ISO 14971

Why Choose OPRx?

ISO Readiness Assessment:

Our highly experienced team offers comprehensive gap analysis services to help organizations prepare for ISO and GMP certification.

ISO Audit Services:

We provide expert audit services and integrate our test plan into your other compliance projects using a "test once, report many" approach.

Take the First Step

Interested in learning more? Complete the form below to quickly connect with OPRx's ISO team. During an introductory call, we will learn more about your organization, challenges and help identify the right next step to protect and grow your business.

Pharmaceutical, Biotech and Medical Device Solutions

What Our Clients Say

Feedback from those we've empowered in the pharmaceutical sector

Portrait of a happy young casual man standing. Portrait of happy fashionable handsome man in yellow t-shirt and glasses crossing hands and smiling

AxoGen, Florida

Ocala Pharms helped streamline our regulatory submissions, allowing us to focus on innovation. Their expertise transformed our approach to compliance!

Curazene, Mexico

The team at Ocala Pharms is unparalleled in their understanding of compliance. They made navigating the FDA process straightforward and efficient.

Portrait of confident Indian businessman wearing eyeglasses, hands in pockets, looking at camera, standing isolated on blue background. Advertisement concept

Intas Biopharmaceuticals, India

With Ocala Pharms, we not only met compliance standards but exceeded them. Their guidance was instrumental in our successful business development platform.

Transform Your Biotech and Medical Device Ventures