Your Trusted Regulatory Partner

Medford Pharmaceuticals offers highly proficient global Regulatory Affairs services catering to all stages of Pharmaceutical, Active Pharmaceutical Ingredient (API), and other health product development and lifecycle management. We pride ourselves on being a dependable and trustworthy Regulatory Partner, committed to ensuring the smooth and compliant progression of your products in the market.

INTERDISCIPLINARY TEAMS

At Medford Pharmaceuticals, our workforce comprises a team of exceptionally motivated professionals, including experienced regulatory affairs (Dossier / DMF) consultants, dedicated scientists, adept trainers, accomplished doctors, and valuable industrial partners. Together, we form a cohesive unit committed to delivering top-notch services and expertise to meet all your pharmaceutical needs effectively. Our combined knowledge and passion drive us to be your ideal partner throughout the product development and regulatory journey.

EXTENSIVE INTERNAL RESOURCES

At Medford Pharmaceuticals, we possess extensive experience in compiling, reviewing, and drafting 350 Dossiers for both semi-regulated and ROW markets. We are well-versed in handling various grades of DMFs across the globe and conducting Bioequivalence (BE) studies. Additionally, we excel in managing numerous ROW dossiers and DMFs, along with various Technical Documents like AMV, SMF, PVP-PVR, PDR, PSUR, PV, and SOP. Our commitment to delivering the highest quality services and exceptional registration dossiers has solidified our position as a trusted and reliable partner in the industry.

IN-HOUSE DOSSIER/
DOCUMENT FACILITY

Medford Pharmaceuticals operates specialized Dossier delivery teams in India, with a dedicated workforce with experienced professionals. Our facility is,equipped with state-of-the-art infrastructure for Dossier compilation and management.


Marketing Applications


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Marketing Applications


NDA / ANDA / BLA / NDS / ANDS / DIN.


Product Lifecycle Management

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Product Lifecycle Management

Supplements, amendments, annual reports, PSURs, PADERs.


eCTD Publishing, ESG & Technical Support

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eCTD Publishing, ESG & Technical Support

eCTD submission publishing, Electronic Submission Gateway and technical support for US, Canada and EU.


Submission Dossier Preparation

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Submission Dossier Preparation

DMFs, PSP, ODDs.


Regulatory Strategy, Gap Analysis & Classifications

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Regulatory Strategy, Gap Analysis & Classifications

Drugs, Biologics, OTC Products, Combination Products, Medical Devices and Disinfectants.


Label Preparation & Review


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Label Preparation & Review


Product Monographs, US Package Inserts, Container Labeling, OTC Product Labeling.


Regulatory Agency Interactions Support

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Regulatory Agency Interactions Support

Pre-IND, EOP2 meetings, pre-NDA/BLA meetings.


Scientific Writing


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Scientific Writing


CMC, Nonclinical, Toxicology Risk Assessments and Clinical.

Let's Improve Healthcare Together

UK Office :

Medford pharmaceuticals UK Ltd

Link Spaces Botanica Ditton Park,
Botanica, Riding Ct Rd,
Slough SL3 9LL,
United Kingdom

bd@medforduk.com

India Office :

Medford Pharmaceuticals

No. 201, 2nd Floor,
Unispace Business Centre Adjt:
Ginger Hotel, EPIP Zone,
Whitefield ,
Bangalore - 560066. INDIA

GET IN TOUCH

+91 806 846 6999
+91 99453 79993,
+91 99453 79992
sales@medfordpharmaceuticals.com