Licensing & Regulatory Approvals at DelExcel Pharma

We prioritize compliance with global regulatory standards to ensure the safety, efficacy, and quality of our pharmaceutical products. Our dedicated Licensing and Regulatory Affairs team works tirelessly to navigate the complex landscape of regulatory requirements, securing the necessary approvals for all our products and processes. We are committed to adhering to the highest industry standards, ensuring that our products meet or exceed the expectations of regulatory bodies worldwide, including the FDA, EMA, WHO, and local authorities in numerous countries.

Global Regulatory Compliance

WHO-GMP Certification

DelExcel Pharma is proud to hold the WHO-GMP (Good Manufacturing Practices) certification, which ensures that our products are manufactured to the highest standards of quality. This certification covers our production facilities, quality control processes, and storage practices, ensuring that our products meet stringent global standards for safety and efficacy.

cGMP Compliance

Our facilities are compliant with current Good Manufacturing Practices (cGMP), ensuring that every aspect of our production processes—from raw material handling to finished product release—follows the latest regulatory guidelines. This compliance is a cornerstone of our commitment to producing safe and effective pharmaceuticals.

US FDA Approvals

We have successfully obtained approvals from the US FDA for several of our products, demonstrating our capability to meet the rigorous standards set by one of the world’s leading regulatory bodies. Our FDA-approved products are trusted in markets across the United States.

EMA Approvals

Our commitment to excellence extends to Europe, where we have achieved EMA (European Medicines Agency) approvals. These approvals validate that our products comply with the stringent quality, safety, and efficacy requirements for distribution across the European Union.

Our Licensing and Regulatory Expertise

Our Licensing and Regulatory Affairs team is highly experienced in securing product registrations and approvals in diverse global markets. Our expertise spans:

Product Dossier Preparation: We compile comprehensive regulatory dossiers in accordance with the specific guidelines of target markets, ensuring seamless product registration.
CTD and eCTD Submissions: We handle Common Technical Document (CTD) and electronic CTD (eCTD) submissions for faster and more efficient product approvals in regulated markets.
Regulatory Strategy Development: We develop customized regulatory strategies that align with your product’s development plan, ensuring timely and successful approvals.
Post-Approval Compliance: Our team ensures ongoing compliance with regulatory requirements post-approval, including periodic updates, renewals, and pharmacovigilance reporting.

Global Licensing Capabilities

At DelExcel Pharma, we actively seek to expand the reach of our products through global licensing opportunities. Our Licensing team works with partners to distribute our high-quality products in both regulated and emerging markets. By leveraging our regulatory expertise, we ensure that our products can be swiftly approved and launched in international markets, helping our partners meet local healthcare demands.

Licensing in Regulated Markets: We offer licensing opportunities in highly regulated markets, including the United States, Europe, and Canada, backed by our FDA and EMA approvals.
Licensing in Emerging Markets: Our licensing team also works extensively in emerging markets across Asia, Africa, and Latin America, helping to meet critical healthcare needs in developing regions.