• regulatory solutions

Our team of knowledgeable writing professionals offer expert consulting and provide optimal solutions leading to minimize the obstacles faced throughout the from drug discovery to commercialization. We design and implement drug registration writing projects specifically tailored to your organization and or products.

Whether you want us to do a project for you or assist your regulatory affairs employees, we are always ready to pitch in! Pharmademics could be a guidance partner to assist your company in navigating the requirements for registration of drugs, health products, cosmetics and medical devices across the globe.

Unlike other consultants we are having experts from QA, QC, Production and Regulatory sector so that documents could be reviewed & compiled in a best possible manner.

We use a blend of operational methodologies, processes, tools, templates and the ‘right & act’ kind of human intellect to deliver our projects consistently upon agreed timelines & quality parameters.

CTD / ACTD / E-CTD DOSSIER COMPILATION AND PUBLISHING SERVICES

  • Design/development & assistance in the preparation of Common Technical Documents (CTDs).
  • Creation of regulatory body specific dossier for effective submission and registration.
  • Drafting of query responses & submission against query letters issued by different regulatory authorities.
  • Preparation and submission of different variation applications

PREPARATION CUM REVISION OF SPC, PIL AND LABELLING

Pharmademics offer several solutions and services in connection with product and patient information, including preparation, translation and revision of:

  • Summary of Product Characteristics
  • Labelling
  • Product Information Leaflet

READABILITY TEST OF PIL (PROOF READING)

Utmost care should be taken to make sure that the product literature has been user tested conformance and is accurately understood by the end consumer i.e. patients. At Pharmademics, we offer solutions by

  • Preparing Protocols
  • Managing PIL readability Tests
  • Proof Reading of Package Inserts & Literatures

MARKETING AUTHORIZATION FILING AND MAINTENANCE

Pharmademics is always having a bucket full of consultancy and guidance on the strategy for choice of regulatory procedure to be opted. We offer Regulatory life cycle management for your pharmaceutical product, including :

  • Preparation, Maintenance & Management of Marketing Authorisation Application (MAA)
  • Preparation, Maintenance & Management of Variations
  • Preparation, Maintenance & Management of MA Renewal and Transfers

THE PHARMADEMICS ADVANTAGE

  • Single step consultancy for all regulatory services
  • Confidentiality of the documents with CDA
  • Cost effective regulatory support
  • Round the clock regulatory support like In-house regulatory department
  • Timely services
  • Post submission and post registration support
  • More priorities to query reply
  • Re-registration support

WE PROVIDE YOU WITH THE RESULTS THAT MATTER:

  • Timely and full approvals and maintenance of regulatory submissions
  • Local knowledge, cultural understanding and personal contacts in emerging as well as developed markets
  • Regulatory services cost-efficiently outsourced

PHARMACOVIGILANCE

Pharmademics PV Solutions

Lets have your safety data secured and decisive without hassles of cost and delay for setting up an entire safety processing system.

We are a combination of offshore and onshore subject matter experts (SMEs) that can satisfactorily serve the entire pharmacovigilance (PV) verticals. Our PV team across the globe is comprised of physicians, pharmacists and medically trained professionals who have already delivered comprehensive, end-to-end pharmacovigilance services & solutions.

We are always passionately ready to assist & facilitate small scale industries to the mid size organizations for setting up safety system from scratch or at any developing stage.

We at Pharmademics provide complete solutions of the PV cycle ranging from full case management (including case intake, data entry, coding, triaging, QC, medical review), periodic safety reports, Qualified Person for Pharmacovigilance (QPPV) services, narrative writing, medical literature review and analysis of cases (signal detection).

As specialist Pharmacovigilance service providers, we leverage our extensive knowledge and experience to provide following cutting edge PV services:

  • Development of Standard Operating Procedures, Work Instructions, Templates, for all PV related activities.
  • Development of Pharmacovigilance Master File (PSMF)
  • Development of Safety Data Exchange Agreements (SDEA)
  • Serious Adverse Event Case Processing of Initial/Follow-up reports
  • MedDRA coding
  • Narrative writing
  • Aggregate Report Writing
  • Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
  • Periodic Adverse Drug Experiences Report (PADER)
  • Literature Search & data Mining
  • Signal Detection & Evaluation
  • Reconciliation of Serious Adverse Events
  • Monthly compliance and status reporting
  • Pharmacovigilance Awareness Training

We have a passion to achieve excellence and satisfaction for the services you need. Pharmademics has efficient, customized and successful PV management, schedule and cost, while supporting safety and compliance with global regulatory requirements.

OUR CLIENTS

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