Regulatory Services

Pharma More provides regulatory affairs services to all clients in pharmaceuticals/healthcare fields and assists them at each step of the specific regulatory process to manage their timely Launch of pharmaceuticals, Cosmetics, Dietary and Herbal Supplements, and medical devices in the client’s interested territories. Regulatory Services include Marketing Authorization Holder, Manufacturing site registration, Product Classifications, Dossier evaluation, and finalization, Dossier submission to Regulatory Authorities, Registration Follow up and post-registration follow up (including product variations) & maintenance of life cycle of product Marketing Authorization.

Training

Pharma More Training Program can help you make a difference. We will work closely with your team to provide the requested training program. Train quickly and conveniently. Our Training Programme includes above image representation.

Consultancy

We offer a full-fledged pharmaceutical business operations consultancy with a recognized track record of success. We ensure that you are able to stay at the leading edge of every major industry issue affecting the Pharmaceutical Industry.

Advice on legal and regulatory issues

Assistance with responses to regulatory inspection CAPA, warning letters, etc.

Troubleshooting on a wide range of technical problems

Advice on facility design, validation, and operation

Review of validation plans and completed studies

Because of our experts, we are able to provide simple and effective guidance, which will benefit your business.

Pharmaceutical Manufacturing Consultancy

We draw on a valuable wealth of experience and knowledge in planning and implementing pharmaceutical manufacturing facilities for all kinds of dosage forms. Our core capabilities lie in these categories.

Feasibility:

Detailed feasibility market studies including market potential and target portfolio.

Regulatory and compliance guidelines.

Technical Support:

Manufacturing facilities setup and design.

Access to quality APIs

Manufacturing:

Local packaging agreements, in-licensing, and generic manufacturing suppliers.

GMP accreditation, local or regional

Marketing:

Company marketing and distribution channels.

Marketing plans.

Personnel:

Access to qualified/professional personnel or partners.

Design and recommend headcount requirements.

MARKET ACCESS

Pharma More provides the following services for all clients in pharmaceutical/health care by Rethinking their approach to implementation and accelerating functional success with the following:

Helping multinational pharmaceutical/healthcare companies that wish to expand into MEA regional market by becoming their agent or helping them find one.

Providing market guidance to select the product and help the companies with the market data.

Providing simple & effective pathways to the company so that they can enter the market.

Marketing plans development including customer acquisition and retention plans.

Implementation adaptation process.

Event management including launch events and standalone scientific meetings.

Market Research management.

Experience in International compliance policies and guidelines.