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SERVICES

Our expertise in global drug development uniquely qualifies us as the provider of a variety of medical and regulatory services.It is important to have these local contacts so as to maximise the chance of a successful outcome in terms of a client’s regulatory strategy and/or licence submission.
Our professionals are all very experienced with many of them being leaders in their own field. As a direct result of the high calibre of our professionals, we are able to provide strategic advice (thinking ‘outside the box’) as well as ensuring compliance with all the current and relevant rules and regulations.

Medical and Clinical Consulting
Consulting on the Complete Product Development Program (all phases)
Reviewing and Assessing Clinical Protocols
Reviewing Safety and Efficacy Related Issues During Product Development
Adjudicating Clinical Data
Worldwide Drug Safety and Pharmacovigilance Services
Clinical Trial Safety Services
Post-Marketing Surveillance Services
Pharmacovigilance Consulting Services
EudraVigilance Reporting
Regulatory Support of New Chemical Entities
Global Regulatory Strategies
Regulatory Support of All Phases of Clinical Development (IND/CTA, import permits, export waivers, GCP auditing, etc.)
CMC (Chemistry, Manufacturing, Control)
Medical Writing
Labeling
Translations of Technical Documents
Coordination of Regulatory Certificates
In-licensing of Products for Marketing in the Emerging Markets
Assessment of Local Medical Need
Assessment of the Local Business Opportunity
Assessment of the Appropriateness of the Existing Documentation for an Approval in the Target Countries
Potential in-licensing of the Product
Serve as the Local Marketing Authorization Holder
Sales, Marketing, and Distribution Performed by a Local Distributor
Postmarketing Regulatory Maintenance
Regulatory Maintenance of Marketed Products
Life Cycle Management of Recently Marketed Products
Regulatory Maintenance of Older Products
CMC (Chemistry, Manufacturing, Control)
Post-Marketing Drug Safety & Pharmacovigilance
Labeling Updates and Harmonization of Labels
Product Transfers
Product Acquisitions (regulatory due diligence)
Company Mergers
Company Acquisitions (regulatory due diligence)
Regional Marketing Deals (co-promotion, co-marketing)
Coordination of Regulatory Certificates
Special Projects
Educational Activities
Training of personnel in pharmaceutical companies
Training of regulatory agency personnel from the emerging markets
Organizing meetings with drug development topics
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please have a look at our Product list

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GMP- GOOD MANUFACTURING PRACTICES



Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages,cosmetics,pharmaceutical products, dietary supplements, and medical devices.


All guideline follows a few basic principles: Manufacturing facilities must maintain a clean and hygienic manufacturing area.Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.Instructions …

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If we will search for RI anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy and legislation. Regulatory Information collectively comprises of three main segments which are followed while performing Regulatory Information activities: • Gather Data: RI professionals perform research about regulatory norms as per a particular product in a particular geography. As far as collecting relevant regulatory information is concerned, there are a lot of sources that RI professionals leverage to consolidate their research material. • Analyse Information: This gathered data needs to be filtered out to obtain relevant information as per the purpose. The data filtered is then rearranged having relevant information required according to lat…