Afra Pharma Consultant Nibm, Pune, Maharashtra

Apc is in product as well technology consulting for pharmaceutical, vaccines, biological, diagnostics and medical devices. apc have associated with an us based organization and representing them in offering technology transfer for the following group of products: bio-technology oncology other products such as:- analgesics antibiotics nsaids gastrointestinal respiratory hormones ophthalmology gynecology dermatology neurology vaccines diabetes aids papilloma, lyophilized and powder related services: support in conceptualization of global business plan and strategy setting up global infrastructure for marketing and distribution enabling strategic tie-ups for technology transfer and global market access portfolio optimization and augmentation advisory for sourcing of products and technology of global repute.

Afra pharma consultant has collaboration with an iso 90001 certified worldwide pharma consulting and engineering company with more than 1600 people at more than 20 locations worldwide and handles up-gradation projects to turn key projects in pharmaceuticals, biopharmaceuticals, medical devices, vaccines and industrial biotech and api. we offer professional services to clients’ specific requirements and take pride in providing current top quality state of the art engineering. we undertake comprehensive management of all project activities, right from conception through completion of construction and commissioning, including continuous monitoring, thereafter to achieve the projected savings in time and money to add value to our services for the benefit of our clients. we also assist in the up gradation of plants in accordance with the latest industry standards. we are proud to state that the facilities we have successfully commissioned, in india and abroad, have complied with the demanding standards and requirements of international companies like conforming to cgmp requirements and us fda & uk mca guidelines. pre audit: afra pharma consultant assists clients to prepare for an imminent regulatory inspection by carrying out one or more mock regulatory audits in advance of the real thing. our consultants will visit the your facility and carry out an inspection in the style of the relevant regulatory body (fda, mhra, ema, saudi fda, gcc etc.) after which we provide: an in-depth, impartial and professional assessment of their current state of compliance a detailed, prioritized action plan for the rectification of areas of non-compliance and vulnerability staff coaching in the sorts of questions which are likely to be asked during the inspection and how best to answer them sound, practical support and advice in the run-up to the real inspection.

We (afra pharma consultant)are a leading pharma consult center based in pune, india. We cater all the activities related to pharma companies. we specialize in regulatory support and can cater to all your needs. we are a one stop solution for pharmaceuticals. our strenghts: regulatory support (regulated and semi regulated markets) ctd, nees, ectd, dmf (saudi fda & gcc as well) dossier support (ready actd and ctd dossiers) clinical and pre-clinical expert reports. Module 3 quality report ba/be studies clinical trials contract manufacturing technology transfer (all formulations & api) exports and tenders turn-key pharma projects pharma training ready to fill pellets joint ventures we are looking forward to your cooperation towards development of concrete business and hoping for a strong and good business relationship in future.

In the fast changing technological and regulatory requirement, we offer online e-training/webinar from industry experts and ex- auditors in: biotechnology& biosimilars pharmaceutical development medical devices regulatory quality management business development gmp manufacturing etc. the courses are cpd (continued professional development) accredited from u.k. access our wide range of training material 24 x 7 and in regional language as well.

Afra pharma consultant offer to conduct, manage and monitor multicentre clinical trials in a wide range of therapeutic areas and monitor be studies in india and abroad. We have a special interest in independent clinical trial monitoring work in india and abroad for sponsors from india and abroad. medical writing & clinical studies bioavailability bioequivalence clinical trial studies analytical solutions reports on bio availability / bio equivalence studies clinical trials studies prepare periodic safety update report (psur) preclinical studies like toxicity, carcinogenicity, and teratology & reproduction toxicity biosciences services: we are in association with iso certified, ichgcp compliant clinical research & consulting firm which is dedicated to provide clinical study related services for pharmaceutical and biotechnology product development sculpted to offer high quality design, conduct and analysis of a clinical trial which constantly try to innovate in order to provide easy solutions to our clients for their prestigious projects. To accomplish this, we strive to provide our clients with exceptional services under one roof for the vast sector of clinical trial management and bioinformatics developments. In clinical research, our services range from site services to sponsor related, regulation of monitoring issues, management of the clinical trial data, precise scientific writing and the developing post marketing strategies; strictly adhering to the respected regulatory compliance summed up with our personal commitment to time management and unbiased report submissions.

Apc has association with pharmaceutical facilities located in india and abroad with facilities having approvals from various international agencies who cgmp, mhra, tga, mcc, anvisa etc. Our service is aim to provide our clients with quality medicines at affordable price. apc offer contract manufacturing for all dosage forms and can even assist apis as well. Depending on needs of our valued clients, our services include purchasing of raw materials, production, packaging and quality control.

Providing high quality drug safety services to pharmaceutical companies, research organizations and health agencies. drug safety services end-to-end case processing (icsrs) - case intake and triage, meddra coding, narrative writing and medical assessment aggregate reporting (pbrer/psur, pader and dsur) preparation and submission of periodic safety update reports (psurs) to competent authorities writing of risk management plans (rmp) / risk evaluation & mitigation strategies (rems). benefit-risk assessment and communication to regulatory authorities and healthcare professionals signal detection & management preparation, review and approval of standard procedures for pv system literature search worldwide literature screening through automated literature screening module clinical trial safety management materiovigilance pharmacovigilance consulting medical information (including call centre support) regulatory safety assistance (pre & post-authorization) standard operating procedures (sops), working instructions (wis) & guidance assistance audits & inspection support training & consultancy implementation of capas pharma covigilance system master file (psmf) preparation turnkey projects in pharma covigilance.