Regulatory Assistance

Regulatory Assistance

Regulatory Assistance That Paves Your Path to Compliance and Market Leadership

O.Berk blends over 75 years of expertise in packaging regulation with cutting-edge solutions. Understanding the pivotal role of being first to market, we are dedicated to ensuring that your product launch is not just timely but also compliant with the latest legislation and regulations.






Your Partner in Navigating Complex Regulations
Our forte lies in offering comprehensive regulatory assistance across various industries including medical devices, pharmaceuticals, cannabis, vitamins, food and beverages, and chemicals. With the ever-evolving regulatory requirements for packaging, our team stays abreast of changes to provide you with the most current and reliable guidance.

Unmatched Resources for Unparalleled Support
O.Berk's extensive database boasts over 10,000 regulatory documents and quality certifications from our manufacturers and their raw material suppliers. This rich repository aids in your product filings, ensuring you meet the regulatory requirements for packaging every step of the way. Our maintenance of technical datasheets for all raw materials and colorants adds another layer of precision and reliability.

Customized Solutions for Your Unique Needs
Leveraging technical drawings and our expansive database, we specialize in building specifications for your packaging components. These tailored specifications not only meet but exceed regulatory requirements for packaging, ensuring both internal and external compliance.

Why Choose O.Berk?
At O.Berk, we don’t just comply with standards; we set them. Our commitment to excellence, combined with our deep industry knowledge, positions us as your ideal partner in the packaging journey. From initial design to final product, we ensure that every aspect of your packaging meets the highest standards of quality and regulatory compliance.

In a world where regulatory requirements for packaging are increasingly stringent, our mission is to provide you with solutions that are not just compliant but also innovative and efficient. Partner with O.Berk to navigate the complexities of packaging regulations with ease and confidence.

Embark on Your Compliance Journey with O.Berk
Ready to lead the market with compliant and innovative packaging? Contact us today to discuss how we can assist you in meeting and exceeding the regulatory requirements for packaging in your industry.

Chemicals Hazard Information and Packaging Regulations
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

TPCH (Toxics in Packaging Clearinghouse)

EU RoHS (Restriction of Hazardous Substances

California Prop 65

MSDS/SDS (Material Safety Data Sheet/Safety Data Sheet)

HARCP (Hazard Analysis and Risk-Based Preventive Controls)

TSCA (Toxic Substances Control Act)

Melamine Statement

USP Testing (U.S. Pharmacopeia)

ISO Certificates (International Organization for Standardization)

BPA (Bisphenol A) Statement

Child Proof Packaging Regulations
Child Resistant Certificate

Food Packaging Regulations Halal Statement

FSMA (Food Safety Modernization Act)/FSSC 22000 Additional Info

GFSI (Global Food Safety Initiative) GFSI (Global Food Safety Initiative): The Global Food Safety Initiative (GFSI) is a non-profit association of industry experts committed to improving food safety along the value chain

Food Safety Certificate

Shelf Life Statement

FDA Packaging Regulations
Elemental Impurity Statement

Extractables/Leachables

FDA Pharmaceutical Packaging Regulations
DMF LOA

Nitrosamine Statement

cGMP Statement (Current Good Manufacturing Practices)

Bovine Spongiform Encephalopathy BSE/TSE Statement

Residual Solvents Statement

FDA Regulations for Food Packaging
Third-Party Audit Certificate

Letter of Continuing Guarantee

FSMA (Food Safety Modernization Act) / FSSC 22000

PFAS (Per- and Polyfluoroalkyl Substances)

HACCP (Hazard Analysis Critical Control Point)

FSVP (Foreign Supplier Verification Program)

Allergen Free Statement

GRAS (Generally Recognized As Safe)

Packaging Regulations NEC
TDS (Technical Data Sheet): A technical data sheet (TDS) is a document provided with a product that lists various pieces of information about the product. Oftentimes, technical data sheets include product composition, methods of use, operating requirements, common applications, warnings and pictures of the product. Certificate of Insurance

BRCGS Certificate (Brand Reputation through Compliance)

USMCA (United States, Mexico and Canada Agreement)

AUSFTA (Australia-United States Free Trade Agreement)

AUSFTA (Australia-United States Free Trade Agreement)

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