Regulatory And Research Services for Regulatory-Services-Coverage-by-Morocco-Market

🇲🇦 Regulatory and Research Services for Morocco

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide complete regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Moroccan market.

Our services comply with DMP, ANSM, ONSSA, EU-aligned cosmetic rules, and global ICH/WHO standards.

📘 Regulatory Services for Morocco

🇲🇦 Regulatory & Product Registration Support – Morocco

We assist companies with full regulatory submission and registration in accordance with:

✔ DMP – Direction du Médicament et de la Pharmacie
✔ ANSM – Agence Nationale du Médicament et des Produits de Santé
✔ ONSSA – Safety Authority for Food & Nutraceuticals
✔ EU 1223/2009-aligned Cosmetic Regulations
✔ Moroccan Ministry of Health
✔ ICH Q/S/E Guidelines

Morocco accepts CTD-format dossiers for pharmaceuticals.

📘 Product Registration Services

• Morocco Dossier Preparation & Product Registration

– Pharmaceutical (Rx/OTC) registration with DMP/ANSM
– Herbal & traditional medicine registration
– Food supplement & nutraceutical registration with ONSSA
– Cosmetic product registration/notification (EU-style safety file)
– Veterinary product registration under Ministry of Agriculture
– Ingredient compliance with Moroccan & EU restricted lists
– Full submission management from dossier → approval

• Morocco Label & Packaging Compliance

– Mandatory French and/or Arabic labeling
– Compliance with DMP + ONSSA labeling rules
– Review of claims, safety warnings, dosage, batch & expiry
– IFU, artwork & packaging development for Moroccan requirements

📗 Drug Master File (DMF) / API Documentation – Morocco

– DMF/ASMF in CTD format for DMP
– Bridging CEP / US DMF / EU ASMF
– GMP documentation (PIC/S/EU/WHO accepted)
– API impurity, stability & safety documentation
– Technical API import approval support

⚗️ Bioequivalence (BE) Study Support – Morocco

– BE protocol design per ICH + Moroccan MOH guidelines
– Acceptance of foreign BE studies (EU/US/India) on case-by-case basis
– Biowaiver support (BCS Class I/III)
– Full BE report preparation for DMP evaluation

🔬 Analytical Method Validation (AMV) Services

– AMV as per ICH Q2(R2)
– Validation of assay, impurities, dissolution, stability
– Submission-ready AMV protocols + raw data + final report
– QC method development and transfer

🧾 Regulatory Consultancy & Compliance – Morocco

– Product classification: drug / supplement / cosmetic / herbal / veterinary
– Local Authorized Representative (local agent) support
– GMP/GDP compliance assistance
– Variations, renewals, PSUR & safety documentation
– Monitoring updates from DMP, ONSSA, ANSM regulations

🧪 Research & Development (R&D) Services – Morocco Market

💊 Formulation Development

– Tablets, capsules, liquids, powders, syrups, injectables
– Stability studies for Mediterranean + North African climate
– Formulation optimization for Morocco regulatory expectations

🧫 Analytical R&D Services

– Assay, impurity profiling, dissolution, stability
– Method development & validation
– Stability studies (real-time & accelerated)

📑 Product Development Reports (PDRs)

– PDR prepared in Morocco CTD format
– Includes formulation, QC methods & stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocols & CSRs as per ICH-GCP (E6)
– Support for clinical study submissions to Moroccan MoH
– Toxicological evaluation per OECD guidelines
– Cosmetic safety documentation (EU-style PIF/CPSR)

🌏 Why Choose Us for the Morocco Market

• Experts in DMP, ONSSA, ANSM regulatory systems
• Strong experience with EU-aligned cosmetic & pharma standards
• End-to-end regulatory & documentation services
• Fast CTD/DMF/AMV compliant submissions
• Global exposure: EU, GCC, ASEAN, US, Africa & ROW

📘 Regulatory & Dossier Documentation – Morocco

Hashtags – Morocco Market
#DossierMorocco #RegulatoryMorocco #DMPMorocco
#ONSSAMorocco #PharmaMorocco #CosmeticsMorocco
#SupplementsMorocco #HerbalMorocco #VeterinaryMorocco
#CTDMorocco #DMFMorocco #StabilityStudies #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Morocco

#BEStudiesMorocco #BioequivalenceMorocco #AMV
#DissolutionValidation #AssayValidation

🧪 Technology Transfer & Safety – Morocco

#TechnologyTransferMorocco #MethodTransfer #MSDS
#PharmaTechTransfer