Regulatory Affairs

Our formulation experts have extensive knowledge of regional and global ingredient databases to ensure consumer products are compliant in terms of safety, efficacy, and claims.

• Analyze and evaluate raw materials and finished product formulation for composition accuracy
• Review against regional regulatory databases to ensure compliance
• Identify the correct legal classification considering the functionality of the product
• Liaise with external vendors and suppliers for collating missing documents to complete gap assessment
• Prepare gap assessment and provide remediation measures
• Review of plant-based ingredients to assess their acceptance in terms of medicinal values and claims to define the product classification
• Creation of Ingredient Lists according to regulatory classification
• Fibers and non-woven material compliance checks as per regional regulations

ClinChoice offers extensive support to identify the need for notifying Health Authorities of ingredients and products based on product information assessments, and timely preparation of supporting documents and notification to ensure the availability of the finished product in the market.

• Analysis of product-market combinations and strategizing submission pathway to ensure successful and timely submission and approval
• Identification of regulatory documentation requirements and timelines based on regulatory intelligence
• Preparation of the documents required to support notification of new ingredients and registration of new products
• Response to questions from health authorities
• Support for import license applications
• Preparation and updates to Product Information Files for EU and non-EU markets
• Support the Voluntary Cosmetic Registration Program by preparing supporting data as per the checklist
• Support cosmetic product notification program for the EU
• Update regulation sections in the Cosmetic Product Safety Report
• Support cosmetics manufacturers for facility registration and product listing as per MoCRA

Our labeling experts ensure that consumers are able to read and understand the necessary information provided on the label, such as ingredients, warnings, allergic formation, and directions for disposal, to ensure zero impact on the environment.

• Preparation and submission of poison center notifications
• Preparation, review, and finalization of artworks and labels to ensure compliance with local regulations
• Creation of an ingredient list based on the final formulation details
• Review of change controls related to artworks and labels to prepare an impact assessment
• Perform gap assessment as per regional requirements to identify gaps and propose remediation measures
• Review of packaging requirements, including specification preparation and finalization
• Ensure labeling compliance by checking the appropriate usage of images, declaration of claims, presence of nanoparticles, and recycle symbols as applicable
• Proofread the labeling graphics against the source documents.
• Reviewing and approving marketing collaterals and promotional materials
• Customization projects for websites, advertisements, product catalogs, social media and other channels and assets
• Verification of regulatory information, including appropriate net contents, statement of identity, drug facts information, ingredient list, font size for all graphic components, etc.

ClinChoice supports change control management by reviewing and evaluating the impact of the change in formulation and ingredients based on country requirements and support notification to the health authority if required. Our services include:

• End-to-end management of change controls related to ingredient changes, formula changes, new vendor qualification, and artwork and labeling changes
• Prepare an impact assessment on the affected products and create the regulatory activity deliverable with the target date
• Follow up with cross-functional teams for review and approval of change control, followed by closure of deliverables for implementation of the change

Our regulatory intelligence experts offer a well-informed regulatory strategy to support market entry and ensure your products remain compliant with local and international standards by providing you with regular updates on the ever-changing regulatory requirements based on your product categories. Our services include:

• Monitor recycling information and other applicable regulations for key markets
• Regulatory landscape assessment for global markets for identified products
• Monitor and update on environmental assessment regulations
• Impact assessment due to health authority updates
• Assessment and strategy suggestions for multiple product registrations
• Comparative analysis of similar products available on the market
• Support marketing requirements to study new claims
• Assess the possibility of including new ingredients by studying similar products available in the market