Regulatory Affairs Services

Reopharm major services help guide branded, generic companies and distributors in meeting regulatory requirements and commercial objectives, for pre- and post-approval risk assessment, risk minimization and any other required studies to achieve goals.

  • Manufacturing site inspection planning, implementing and coordinating, with health authority inspectors, to ensure initial success, and meet requirements before due inspections, in order to obtain certification from related regulatory authorities.
  • Manufacturing site registration consultant services offered by the Reopharm regulatory team to enhance your business setup and global reach.
  • Obtaining a product registration certificate and ensuring that all file documents conform with the regulatory requirements approved by a health authority in each target market. A follow up to maintain product registration renewal based on the period decided by regulatory authorities.
  • Offering a joint venture contract between client manufacturing sites in global markets, and other manufacturing sites in targeted markets, thus initiating company and product registration as well as doing business. Arranging all documents needed, to match with regulatory affaires’ requirements. Ensuring legal rights for each party through negotiation, and preparation of a contract draft to agree on and later to be signed.
  • Delivering all regulatory advice regarding packaging material starting from the confirmation of the product leaflet, contents and its translation, followed by the legalization of a regulatory affairs authority in each targeted market. Ensuring your new version package will be approved by the regulatory affairs authority.
  • Ensuring Regulatory Compliance in chemistry and manufacturing.
  • Controlling Regulatory Compliance Designed to ensure Product Success.
  • Meeting Compliance Regulations in the Medical Marketplace.
  • Safety Reporting that Meets Both Regulatory Agencies’ and Your demand.
  • Risk Management Planning.
  • Response to agency enquiries and meet with them.
  • Advisory Committee preparation.
  • Scientific Advice and Protocol Assistance.
  • Lifecycle management.

Post-marketing follows up

Post-marketing activities play a major role in the product lifecycle. The Reopharm regulatory team will ensure your product Licence is correct, valid and safe.

Proceeding in various global markets

Reopharm specialists help with all your post-marketing activities in order to increase your company benefits, for example:

  • Renewals
  • Line extensions
  • Pharmacovigilance

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Labeling, packaging and advertising are continuously changing and improving. Reopharm offers effective communication, and sticks to local regulatory requirements to ensure the safety of the patient.

Whether finished product or semi-finished product, preparation of a common technical document (CTD) is a module to ambitious International Quality Compliance initiatives. Our team is ready to offer training, in order to upgrade your regulatory capabilities thus meeting each targeted market requirement.

Outsourcing You Trust

Getting product approval is the only way to maintain your profitability and continue growing. Don’t waste your time working on regulatory affairs to maintain the approval of medication that has already been approved.

Outsourcing is a strategic management choice that saves time, money and effort. By using an outsourced method you achieve your Goal more efficiently and at a lower cost. Reopharm Consulting Regulatory Outsourcing Services are:

  1. New product file submissions
  2. Regulatory compliance maintenance
  3. Pharmacovigilance and labeling maintenance
  4. Emerging and non-emerging market support

Click here to view the lists of our Regulatory Affairs Documents.

 

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CONTACT INFO:

Canada Head Office:

100 City Centre Drive
Mississauga, Ontario
Canada
Tel: +1 (416) 871-2314

Marketing Department:
Email: info@reopharm.com



Regulatory Affairs Services