Regulatory Assistance

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At Protheragen, we understand that regulatory compliance is essential in the pharmaceutical and compounding industries. That's why we've built a global network of regulatory consultants, compliance experts, and regional agencies—allowing us to provide clients with tailored, up-to-date regulatory assistance across markets.

Whether you're sourcing APIs for manufacturing or ingredients for compounding pharmacies, we coordinate with experienced partners to ensure that your materials meet all applicable documentation, safety, and regulatory standards.

With heightened oversight from the FDA, DEA, State Boards of Pharmacy, and international health authorities, the right documentation is no longer optional—it's critical to market access, patient safety, and audit readiness. Protheragen and our global partners are here to help you navigate it.

Our Regulatory Support Capabilities

We provide end-to-end documentation and compliance assistance, tailored to your needs and your region's regulatory framework.

Regulatory Dossier Preparation for Selected APIs

We support clients in preparing regulatory submissions through coordination with licensed experts and agencies. This includes:

Full or partial CTD dossiers
Drug Master File (DMF) referencing or registration (US, EU, Canada)
Product technical files, stability summaries, and manufacturing process documents
Support for local adaptation of dossiers per jurisdiction.

Formulation Legality Review for 503A and 503B Compounding Compliance

With help from U.S.-based regulatory consultants, we assist compounding pharmacies and outsourcing facilities in determining whether a given formulation is legally compoundable under FDA and state-specific guidelines.

Review of ingredient status on FDA's Bulk Substances List
Evaluation of USP monograph alignment
Assessment of 503A vs. 503B limitations
Support for prescription-based vs. office-use decisions

USP <795>, <797>, and <800> Compliance Support

We coordinate with specialists in compounding compliance to help clients meet U.S. Pharmacopeia standards:

Documentation for storage, beyond-use dating, risk levels
Material compatibility and safety assessments
Support for hazardous drug declarations and containment needs
Facility and labeling reviews as needed

DEA and Controlled Substance Classification Guidance

Through licensed DEA compliance advisors, we provide classification and handling insights for scheduled substances:

Schedule II-V documentation
DEA license and storage setup
Guidance on state and federal dual compliance
Support for import/export requirements across regions

Labeling Guidance and Verification (FDA and State Board Compliance)

We and our labeling compliance partners assist in verifying that your packaging and labeling meet state and federal requirements:

Drug identification, batch number, expiration, strength
Cautionary statements and 503A/503B requirements
Custom label guidance for repackaged or bulk APIse

Ingredient Sourcing Traceability and Material Origin Documentation

We ensure traceability of raw materials by working with qualified manufacturers and audit partners. Documentation includes:

Country of origin declarations
Manufacturer certifications and audit reports
TSE/BSE-free and GMO-free statements
Supply chain transparency records

GMP and Quality System Alignment Support

Together with GMP consultants and QMS advisors, we help you align your operations with global quality standards, including:

Supplier qualification templates
Change control and documentation protocols
GAP analysis between local and FDA/EU GMP
Quality agreement preparation and support

Why Choose Protheragen?

Global Network of Regulatory Experts

We bring together region-specific knowledge and industry experience through partnerships in North America, Europe, and Asia.
Scientific Oversight

Our internal scientific team coordinates technical accuracy across all submissions and documentation packages.
Customizable Documentation Sets

From basic COAs to full CTD dossiers, we tailor our deliverables to meet your target market’s expectations.
Seamless Coordination

You work with one point of contact—we manage the rest with our network of vetted regulatory professionals.

Whether you're preparing for a state board inspection, submitting a 503B outsourcing application, or compiling a regulatory dossier for an IND, we and our partners are ready to support your documentation and compliance journey. Contact us today to request documentation, schedule a consultation, or build a custom documentation package.

We provide the platform, technical oversight, and global coordination—while our partners execute with precision. Contact us to get started with our one-stop regulatory assistance.