Regulatory Affairs Specialist
Comprehensive Global Regulatory Support for Pharmaceuticals and Medical Devices
At NDV Healthgrid Private Limited, we specialize in providing end-to-end Regulatory Affairs solutions to pharmaceutical, biotechnology, and medical device companies across the globe. With our expertise and deep understanding of international regulatory frameworks, we assist clients in preparing, compiling, reviewing, and submitting technical documentation for successful approvals in various global markets.
Our goal is to streamline your product registration process while ensuring complete regulatory compliance across multiple jurisdictions.
Our Regulatory Services
We provide a full spectrum of services covering regulatory submissions, data compilation, and documentation:
1. eCTD (Electronic Common Technical Document)
Preparation and publishing of eCTD dossiers for regulatory submission in accordance with region-specific requirements.
2. CTD (Common Technical Document)
Structured preparation and formatting of CTD submissions for both originator and generic products.
3. ACTD (ASEAN Common Technical Dossier)
Expert support for compiling ACTD submissions compliant with ASEAN guidelines for Southeast Asian markets.
4. CEP (Certificate of Suitability)
Preparation and submission of dossiers for obtaining CEP through the EDQM for active substances.
5. USDMF (United States Drug Master File)
Compilation and filing of USDMFs for APIs, intermediates, and excipients as per FDA requirements.
6. ANDA (Abbreviated New Drug Application)
Complete ANDA documentation for generics, including bioequivalence studies, CMC, labeling, and administrative components.
7. Technical Data Compilation
Preparation of high-quality technical files, including formulation, stability, method validation, and process validation.
8. Dossier for Medical Devices
Preparation of Technical Files and Dossiers for CE marking, FDA approval, and other country-specific requirements.
9. Chromatography Study & Validation
Generation and validation of chromatography data for regulatory submissions, including method development reports.
Global Regulatory Coverage
We provide regulatory support and dossier submissions in over 80 countries, including major and emerging markets:
Countries We Serve:
United States (US)
European Union (EU)
Korea
China
Rest of the World (ROW)
Ukraine
Armenia
Azerbaijan
Latin American Countries (Brazil, Mexico, Argentina, etc.)
And 80+ more countries across Asia, Africa, CIS, and the Middle East
Our region-specific expertise helps ensure that all submissions are compliant with local regulatory requirements, avoiding delays and rejections.
Why Choose NDV Healthgrid ?
Experienced Regulatory Experts: Our team brings extensive experience across various dosage forms and regulatory regions.
Global Reach: Proven track record in over 80 countries.
Customized Solutions: Tailored regulatory strategies based on product type and target market.
Speed and Accuracy: Timely submissions with full regulatory compliance.
Support Across Lifecycle: From development and registration to post-approval variations and renewals.
Industries We Serve
Comfort and familiarity of home environment
Reduced hospital visits and risk of infections
Peace of mind for family members
Dedicated attention and holistic care
Improved quality of life and emotional well-being
Let Us Handle Your Regulatory Challenges
Whether you are launching a new product or expanding to new markets, we offer the regulatory expertise and technical support to accelerate your path to approval.
Email: bd@ndvhealthgridprivatelimited.com
Contact: +91 8091667605
Name of Contact person:- Raj Sharma
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Let Us Handle Your Regulatory Challenges
Whether you are launching a new product or expanding to new markets, we offer the regulatory expertise and technical support to accelerate your path to approval.