In a rapidly evolving regulatory landscape, health and beauty brands face increasing scrutiny. Whether it's a food supplement promising enhanced wellness or a cosmetic product offering skin rejuvenation, regulatory compliance is no longer optionalit's a critical component of successful market entry and long-term brand integrity.

AtDDReg Pharma, we specialize in end-to-endRegulatory Affairs Services for Food Supplements and Cosmetics, helping clients worldwide navigate the complex maze of global compliance with confidence and ease.

Why Regulatory Compliance Matters

With increased consumer awareness and government oversight, the bar for product safety, efficacy, and transparency has never been higher. Non-compliance can lead to:

• Product recalls

• Market access delays

• Regulatory fines

• Damage to brand reputation

Our mission atDDReg Pharmais to simplify compliance and help you launch your products seamlessly across global markets.

Food Supplement Regulatory Services

Food supplements industryfall into a unique category between food and medicine, making their regulation particularly challenging. Different regionssuch as the EU, US (FDA), Middle East, and Asiahave varying definitions, rules, and approval processes.

Our services include:

• Regulatory Classification: Determining whether your product qualifies as a food supplement or falls under a different category (e.g., nutraceutical, novel food).

• Ingredient & Formulation Review: Ensuring all components meet the safety and legal requirements of your target markets.

• Labeling Compliance: Verification of label claims, nutritional information, and mandatory warnings.

• Dossier Preparation & Submission: Compilation of all technical documentation needed for registration or notification.

• Market-specific Guidance: Tailored strategies for compliance in key global regions including the EU, GCC, ASEAN, and Latin America.

Cosmetics Regulatory Services

Thecosmetics industryare closely monitored for consumer safety and product efficacy. From skincare and personal care to beauty products, each item must comply with stringent local and international regulations.

Our services include:

• INCI and Ingredient Review: Evaluation of ingredients against approved cosmetic lists and prohibited substances.

• Labeling & Claims Substantiation: Review of marketing claims to ensure they are scientifically and legally supportable.

• Cosmetic Product Safety Reports (CPSR): Preparation of mandatory safety assessments required under EU Regulation (EC) No. 1223/2009.

• Product Information File (PIF) Compilation: Complete technical file management including product description, GMP declaration, and safety testing results.

• Cosmetic Notification Portal (CPNP) Submissions: Handling all aspects of notification within the EU and other regional equivalents