Regulatory requirements of Cosmetics and Personal Care Products (PCP) vary from country one country to another. For example regulation EC1223/2009 for the European Union (EU), (21 CFR part 700) for the US FDA, the Cosmetic Directive (ACD) for The Association for Southeast Asian Nations (ASEAN), the Food and Drugs Act in Canada, The Pharmaceutical Affairs Law (Law No. 145) in Japan, and ANVISA Law # 6.360 in Brazil. Furthermore, cosmetics and PCPs can be classified into different categories depending on the country; General Cosmetics, Functional Cosmetics, Organic Cosmetics, Grade -I and Grade-II Cosmetics, Controlled Cosmetics (CC), Specially Controlled Cosmetics (SCC), Over-the counter Cosmetics (OTC), Low-Risk and High-Risk products , are examples of terms that exist in regulation. To overcome the complexities of cosmetic regulation Global Regulatory Partners, Inc. offers a comprehensive range of services for Cosmetics and Personal Care Products to ensure products meet the latest cosmetic safety regulations. With regional offices in Europe and North America, Latin America, and the Asian Pacific (APAC) GRP is well-positioned to support your regulatory needs globally. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and PCPs. GRP helps manufacturers, distributors, and marketers of cosmetics.
Authorized Local Agent
GRP has local offices and strategic partners worldwide that are licensed by local authorities. GRP can act as your local agent in many countries for your cosmetic and personal care products.
Cosmetics are regulated differently from country to country. While some countries require registration of cosmetic products others only require a notification. GRP experts can collect the regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in a market.
Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.
Global regulatory Partner, Inc. provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.
Developing the right regulatory strategy for your products for different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets. Our strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals and timelines, the regulatory requirements related to your product, cost, and risk assessment. With a global presence and a local team of experts, GRP regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.
Cosmetic Packaging and Labeling Review
Cosmetic’s package labeling is crucial for product compliance with local regulations as it should provide enough information for consumers so they can use the product safely within its intended use. Package labeling should include in most cases, the list of product’s ingredients, intended use, warnings and caution, direction for use, storage and usage conditions and expiry date as applicable. The requirements for the content of package labelling, the language of the labeling, and other specific requirements vary from region to region. Each region has its own cosmetics labeling requirements and regulations. In USA, manufacturers must comply with the Food Drug and Cosmetic Act and the Fair Packaging and Labeling Act, in Canada, they must follow Canada’s Food and Drugs Act, Cosmetic Regulation and the Consumer Packaging Label Act and in Japan they must comply with the Ministry of Health, Labor and Welfare (MHLW) Pharmaceutical and Medical device Law (PMDL).
Global regulatory Partners, Inc., provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate region-specific regulations, manufacture and sale compliant products.
GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with local and /or regional requirements and the products can be used safely by consumers.
Product Classification & Formulation Review
Most countries have their own list of approved ingredients that can be used in cosmetics and PCP formulation. Additionally, Health authorities (HA) update the list of approved ingredients and information related to their proper use and safety levels constantly. Global Regulatory Partners Inc. provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling.