Ashford Laboratories provides a flexible, dependable, high quality, pioneering regulatory affairs support to all its clients. Ashford advises on and provides support for the subject of market access with professional excellence and creative ideas. We are fully acquainted with the legal requirements for prescription and OTC drugs, biologics, nutraceuticals, supplementary balanced diets and cosmetics. We are also fully aware of the opportunities and hurdles these laws present. Thanks to our wide range of expertise, we will also help you with borderline product issues.

We work with global regulatory resources providing 24/7 cover to streamline and expedite approvals, renewals and regulatory responses.

We maintain constant surveillance over the rapidly evolving regulatory policies and monitor international trends to ensure refined regulatory solutions to our clients.

Ashford Laboratories provides a continuum of regulatory support allowing you concentrate on the other aspects of your business. Indeed, we retain strong links to specialist consultancies and service providers to support the full range of pharmaceutical and clinical development of bio/pharmaceutical products through licensure and beyond.

Ashford Laboratories provides a “virtual regulatory department” service where all regulatory operational activities are undertaken and completed on client’s behalf.

REGULATORY OPERATIONS
A bureau service for the regulatory activities spanning the following areas
        Preparation of license Variations and renewals for existing marketing authorizations.
        Reformatting / preparation of license applications.
        Patient Information Leaflets and readability testing – ensuring patient readability of Patient Information Leaflets and            Package Leaflet.
        Interim Department support / Virtual Regulatory Department - for clients who do not have their own dedicated office,            or who have taken the decision to outsource the regulatory affairs function.
        Submission of Marketing Authorisation Applications (MAA) - preparation, submission and management of MAAs through            the Mutual Recognition, Centralized, or National Application procedures. This cover includes both innovator and generic            products.
        CTD-summaries/overviews - writing and assessment of non-clinical and clinical overviews/summaries and quality            overall summary.
        Provision of Expert Reports.

OUR STRENGTHS

        We can provide clinical Trials, FDA Certificates and BE Studies for registration of our products as per guidelines of            most health authorities in most countries.
        Most of our products are ready with DMF`s, Dossiers, Free Sale Certificates (FSC) and Certificate of Phamceutical            Product (CPP/ COPP`s). Registration files are supported for international regulated markets with the help of our highly            qualified regulatory team.
        We can provide quick and smooth attestation of documents from the Ministry of External Affaris (MEA) and various            embassies/ consulates.
        Analysis of regulatory hurdles and opportunities for human and veterinary medicinal products, food supplements,            supplemental balanced diets, medical devices and cosmetics
        Advice on issues relating to borderline products
        Evaluation of intended product claims and/or indications
        Marketability testing of formulae, product positioning, advertising claims
        Evaluation of borderline products
        Complete knowledge about BE and eCTD submission.

We find the right balance of regulatory affairs and product management for your products so you can take advantage of all economic opportunities. We welcome opportunities to work with International Pharmaceutical Companies.