Expert Regulatory Services for Pharmaceuticals

Your Partner in Regulatory Success

Expert regulatory services for the industry, tailored to meet your unique needs and ensure timely market access.

150+

15+

Senior Regulatory Expert

Happy Customers

3000+

Order completed in past 15 years

Regulatory Services Expertise

Tailored regulatory support for exporting companies navigating complex global requirements efficiently.

Dossier Preparation Support

Expert assistance in preparing and submitting regulatory dossiers for timely market entry.

DMF Management Services

Comprehensive management of drug master files to ensure compliance and efficiency.

Customized regulatory solutions for diverse pharmaceutical needs across various global regions.

Regulatory Consultation Services

Our Services

Dossiers & DMF

PDDS write (prepare / Draft) and review dossier as per European CTD / ASEAN CTD / ROW-CTD /non-CTD (country specific guideline)

Supporting exporting companies in navigating complex regulatory landscapes efficiently.

BE and Clinical & non-Clinical

BE, CT Report, PSUR, M2 Overviews, M4, M5, Toxicity report, Biowaiver report

Analytical Method Validation

AMV-Assay, Dissolution, Impurity and Residual Solvent Format and Content : As per ICH / ASEAN / WHO / other country specific guideline
Products:- Pharma Formulation, Bulk (API) & Veterinary

Product technology

Batch formula, process or MFR or BMR; CDP & PDR; PDDS provide Stable, validated and BE passed technology (Formula & Process)

Supportive Services

Document Writing Services - For Formulation Dossier & API DMF Best Quality - Query-free - Reasonable Price

Dossier Conversion

CTD to ASEAN CTD or ROW dossier and Vice-versa

Pragya Dossier-DMF Services streamlined our regulatory process, making our product launch efficient and successful.

Dr. Rodriguez, Europe

★★★★★

Our Location

Visit us to discuss your regulatory needs and how we can assist you in navigating the pharmaceutical landscape effectively.

Address (Marketing Office)

Plot 13, Sector 19, A 3 , Bhimashankar CHS, Nerul, Navi Mumbai, Maharashtra 400706, India

Hours

Monday - Friday: 9:00 - 18:00 Saturday: 9:00 - 16:00 Sunday: Closed

Operational Sites

Dossier- DMF R&D site (Pharma)- Plot No. 63, 76 and 77 APIIC Industrial Park, NH42 Madanapalle, Andhra Pradesh 517325, India

Regulatory for cosmetic and Nutra- Plot No. G4 & G6 , RIICO Industrial Area, Naya Gaon, NH162 District- Pali, Rajasthan, 306401 , India

Regulatory for Ayurvedic and Herbal- - RIICO Industrial Area, Boranada Phase I, Jodhpur, Rajasthan 342012 India

Document Processing office- Plot No 40, Kharsa No 2051/33 , PDDS Building, Near Sojat Road Marg, Landmark, NH162, Sojat, Rajasthan 306104