Regulatory Assistance
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At Protheragen, we know the importance of regulatory compliance in pharma and compounding. That's why we have a network of regulatory consultants, compliance experts and regional agencies. It helps us offer clients personalized, on-demand regulatory assistance, updated to reflect market requirements.
Whether you're sourcing APIs for manufacturing or ingredients for compounding pharmacies, we work with a network of experienced partners to help you be sure that your materials are properly documented and meet safety and regulatory standards.
With increasing scrutiny from the FDA, DEA, State Boards of Pharmacy, and global health authorities, the right documentation is not just a nice-have. It's critical to market access, patient safety and audit preparedness. Protheragen and our global partners can help you navigate it.
Our Regulatory Support Capabilities
We offer end-to-end documentation and compliance support, customized to your needs and your region's regulatory requirements.
Regulatory Dossier Preparation for Selected APIs
We can assist clients with regulatory submissions, either by coordinating with licensed experts or agencies for:
- Full or partial CTD dossiers
- Drug Master File (DMF) reference 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 dates, risk levels
- Material compatibility and safety assessments
- Support for hazardous drugs 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. - Tailored Document Packages
We design your package of deliverables to fit your target market – from basic COAs through to full CTD dossiers. - Central coordination
You have one point of contact – we coordinate your work with our network of carefully selected 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.