Regulatory Affairs Service Provider in Morocco

The MoH (Ministry of Health), the Government of Morocco, and ANAM (National Health Insurance Agency) are the prime regulatory organizations accountable for Morocco’s general healthcare admission and rules. The MoH is responsible for designing and executing government guidelines on public health. The Department of Pharmacy of MoH licenses the transaction of new medications in the country based on safety and effectiveness data. Any medication, created locally or imported, even at the example level, must acquire authorization from the Department of Pharmacy, MoH, before deal or allocation (even complimentary). Moreover, this authorization is essential before any medication can be considered for repayment. The MoH declares that a license can only be allocated if the medication meets exact requirements for proper testing to emphasize effectiveness, guarantee its safeness under standard prerequisites, confirm its medicinal value, and demonstrate bioequivalence for a generic drug.

Why choose DDReg as a Regulatory Consultant in Morocco?

As a leading global contender, DDReg’s Regulatory Services in Morocco provides ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high-quality and timely regulatory submissions . We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filing and market authorizations.

Our Regulatory Consulting Services In Morocco Portfolio Covers

Country Specific Services

Our Regulatory Affairs Consulting Services in Morocco portfolio covers:

Regulatory Strategies
01

Regulatory Strategies

The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...

New Product Marketing Authorizations
02

New Product Marketing Authorizations

Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...

Gap Analysis and Remediation
03

Gap Analysis and Remediation

In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...

Regulatory Due Diligence
04

Regulatory Due Diligence

Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...

API & DMF services
05

API & DMF services

Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...

CMC Advisory
06

CMC Advisory

DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...

Post Approval Life Cycle Management
07

Post Approval Life Cycle Management

Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...

Certification Services
08

Certification Services

Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...

ANDA and MA Holder Services
09

ANDA and MA Holder Services

Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.

Publishing & Submission
10

Publishing & Submission

Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...

Labeling
11

Labeling

With experts experienced in Consumer Health Care (CHC) products, we offer updated labeling and compliance packages that assist in the development of product labeling, artwork review & compliance, and claim substantiation.