Navigate U.S. FDA regulations with confidence through our expert FDA compliance services for drug exporters. We assist pharmaceutical manufacturers and exporters with product registration, labeling review, documentation, and regulatory submissions to ensure smooth and timely market entry into the United States.
FDA Compliance Drug Export Services,
The opportunities of exporting pharmaceutical products to the United States are enormous in terms of business opportunities – yet it is accompanied by one of the most challenging regulatory systems in the entire world. The manufacture, labeling of drugs, and their importation to the United States of America is highly regulated by the U.S. Food and Drug Administration (FDA) to guarantee the safety and quality of the products to the populace.
We are Compliance Network and our business deals with assisting international drug manufacturers, exporters, and distributors with the entire gamut of FDA compliance requirements. Registration of facilities up to cGMP audits, listing of drugs and import preparedness, we guarantee that your operations are well within all the regulations requirements and when your products get into the U.S. market, they are accepted to be of high quality.
The reason why FDA Compliance is important to Drug Exporters
All prescription, over-the-counter (OTC), and generic drug products imported into the U.S are regulated by the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR regulations by the FDA.
Non-compliance can result in:
- Cargo rejections or U.S. port holds.
- Alert and warning letters of import.
- Recalls of the products or market withdrawal.
- Law suit or damaged brand reputation.
Compliance is not only a legal requirement, it is a competitive edge that creates trust with regulating bodies, distributors and consumers. Compliance Network assists you to bring your processes and documentation into compliance with what the FDA anticipates and have the minimum amount of risk and the shortest possible time to enter the U.S. pharmaceutical market.
Drug Exporter FDA Compliance Services
Our offer is all the range of compliance solutions to drug exporters, which involves every stage of the process, including production and post-market surveillance.
1. U.S. Agent Services Drug Establishment Registration
Before any foreign drug manufacturer or repackers could ship any products to the United States, they have to register their establishments with the FDA.
Compliance Network will assist in:
- Registration of the facility via the Electronic Drug Registration and Listing System (eDRLS) of FDA.
- Registration data is renewed and updated annually.
- Assigning a competent U.S. Agent to communicate with FDA, receive notices of inspections and investigations.
We make sure that your establishment is well registered and available to FDA inspection at any given time.
2. Assistance Drug Product Listing & NDC Number
All drugs that are to be commercially sold in the U.S. have to be registered at the FDA and be provided with a National Drug Code (NDC).
Your product listings are done by our experts and all the necessary information such as formulation, packaging, labeling, dosage form and manufacturer information are sent correctly. We also will lead you on how to make compliant NDC labeling to prevent rejection in importation.
3. Good Manufacturing Practice (cGMP) Compliance
All drug manufacturers that provide the U.S. market are obligated to comply with regulations of cGMP (21 CFR Parts 210 and 211).
Compliance Network performs extensive cGMP audits to determine compliance breaches in your quality system and an outline of a corrective action plan. We assist with:
- Installation or improvement of the quality system.
- Documentation and development of SOP.
- Equipment validation and process validation.
- Staff development and internal audit.
- Processes of batch review and release of records.
We are aimed at ensuring that your facility is always inspection-ready in their compliance.
4. Labeling & Packaging Compliance
One of the most regulated aspects of the FDA regulation relates to drug labeling. Wrong or false labels may lead to arrest or non-admission during customs.
We conduct thorough reviews of labels to make sure that your product is in compliance with the FDA-related requirements, including:
- Declarations of active and inactive ingredients.
- Correct dosage protocol and precautions.
- Presentation of Drug Facts panels (regarding OTC products) in U.S. compliant format.
- Standards of lot number and date expired.
- Serialization, barcode and tamper-evident packaging.
Your labels are read and understood properly, accurately and to the fullest expectations of the FDA.
5. OTC Monograph/ANDA Submission Support
In case of non-prescription drugs, OTC monographs should be adhered to. When your product does not fit into an already existing monograph, then you will have to submit a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Compliance Networks is the solution that assists in identifying the right regulatory route, evaluates your formulation and makes documentation to facilitate submissions required by the FDA. We also help you in setting bioequivalence trials, labelling conformity and marketing licensing mandates.
6. Import Checking and Review of the Entry
Even the compliant manufacturers fully can be subjected to a custom hold in case there is an incomplete import documentation. We are fully supportive of the importers and exporters by making sure that:
- Code and declarations of products are identical to the FDA database.
- Responsibilities of Importer of record are established.
- Prior Notice and custom documentation is duly registered.
- Labeling, shipping paperwork, and FDA registration information are congruent.
Our crew assists you in losing the expensive delays in shipment and provides the easy passage through the customs.
7. Adverse Event Reporting Post-Market Surveillance
Once your products are in the U.S. market, you will have to adhere to the post-market activities, e.g., Adverse Event Reporting (AER) and complaint handlings.
Compliance Networks sets up or oversees your post-market surveillance systems, assists you in dealing with:
- Pharmacovigilance reporting
- Negative event analysis and reporting.
- Product recall readiness
- CAPA (Corrective and Preventive Action) plans
We assist you to ensure that there is constant compliance and safeguard your reputation in the market.
8. Preparation and Response Management on FDA Inspection
FDA inspections are not easy, in particular, foreign facilities are not an exception. Our professionals make you inspection ready by:
- Mock FDA audits
- Document review and training of personnel.
- Checklists Pre-inspection compliance checklists.
- Assistance in preparing answers to the Form 483 observations or Warning Letters.
We assist you to react suitably and in a professional manner to any FDA discoveries to diminish chances of enforcement measures.
Why Choose Compliance Networks
Market Experience: We are the inside story on pharmaceutical regulations – raw material sourcing, labeling and post market safety.
End-to-End Solutions: Registry, documentation, audits, labeling and U.S. agent services are done in a single streamlined process.
International Attainment: As the exporter of drugs in the world, we ensure that the FDA compliance is convenient and effective to all our global partners.
Regulatory Accuracy: All documents and procedures are checked by the professionals to be accurate and timely.
Continuous Support: After registration, compliance does not conclude. We offer ongoing monitoring, renewals, and assistance to have your company FDA ready.
Get FDA-Ready Drug Exports with Compliance Networks
FDA drug regulations may be tricky to maneuver through and with the right partner it becomes an easy process that can be easily handled. Compliance Networks offers full regulatory assistance which secures your business, complies and speedy entry to the United States market.
Make the initial move towards regulatory, effective and successful pharmaceutical exports.