Pharmaceutical Dossier Management

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Pharmaceutical Dossier Management

We are a global pharmaceutical regulatory techno commercial consultancy services. We assist pharmaceutical and life sciences industries for both human and veterinary to register their products and access the rapidly growing diverse markets throughout the world. We provide regulatory services for dossier submissions such as DMF / CTDs-ACTD / ANDA / Validations / cGMP / GLP / PSUR / BA-BE Studies.

In and out licensing of Dossiers and advise you on strategic, cost effective and innovative product development planning system setups for cGMP according to WHO/USFDA/MHRA/MCC/ICH Guidelines as well as GMP compliance, starting from Plant Design to GMP approval by any regulatory Agency Worldwide.

We help you to increase your professional standards in Pharma background in the following manner:

We provide support by giving post submission query response and the expert’s opinion on the same.

We do provide technical advise for scale up and tech transfer of related projects for finished formulations; various dosage forms and legal services.

 

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1 Comment
  • Caroline Ademiluyi
    Reply
    Posted at 4:22 pm, August 28, 2019

    We wish to have a dossier done for us with the following details; Name of Product; Levamisole tablets for human use. The dossier should be in CTD format and in accordance with guidelines for the National Agency for Food and Drug Administaration and Control(NAFDAC). We look forward to getting a response from you.

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