Global Drug & Medical Device Regulatory Consulting

• Regulatory Affairs at US-FDA

 Drug & Medical Device Regulatory Consulting

CliniExperts have aligned themselves with the internationally renowned regulatory consulting companies. These companies have a proven track record in drug, medical device, and regulatory consulting and has been providing services since 1987. Their experienced regulatory consultants bring a wealth of knowledge of the most up-to-date regulations, directives, laws, policies, and guidelines and recommend the right course of action for an organisation. These are positioned to act as Regulatory Department on an “as needed” basis, offering significant cost savings. These regulatory consulting services include:

• Regulatory strategic planning from design to market (Fast Track, orphan drug, drug vs.cosmetic, etc.),

• Product Classification Review (devices, drugs, combination products),
• FDA meeting management for key milestone meetings with regulatory agencies (Pre-IND, Pre-IDE, End Phase 2, etc.),
• medical devices regulatory support for 510(k), IDE and PMA,
• OTC drugs: Rx-to-OTC switch, Time and Extent Application,
• US agent status for non-US companies.

• Global Licensing and Registration

We are fully experienced, and have specialised skills in providing assistance to international pharma companies who want to register their products in the USA and the European Union. We are also highly adept at managing the registration process for other countries in Europe, Africa, Asia, the Middle East and South America.

We work closely with the highly respected US regulatory consultancy, Strategic Regulatory Consulting.

The CliniExperts team can advise and develop all relevant dossiers that meet specific ACTD, EU CTD, eCTD requirements pertaining to all the scientific disciplines required for successful registration of products in Asian countries, the European Union, and all other countries.

• Product Registration Process – a strategy that ensures optimum results

At CliniExperts, we measure our success by the time it takes to secure a product registration through the appropriate regulatory authorities. In this we have an enviable reputation for efficiency and competence.

Initially, we ensure that all data provided by our clients is carefully scrutinised to ensure its adequacy and accuracy. We can guide and advise our clients beforehand so that the submitted data fully meet the requirements for product registration, and eliminates any risk of delay. We also conduct an independent review of the available data to ensure that any potential deficiencies are identified beforehand and corrected during the dossier development process.

For each task, a technical specialist is allocated – either from our in-house team, or from aspecialised subcontractor – to ensure efficient project management. A project milestone plan is created and communicated to the client and when the client is satisfied with the logic and timings of the draft plan, the project is initiated for subsequent delivery on time.

A detailed regulatory submission strategy is developed and the dossier documents pertaining to product registration are prepared in sync with the regulations and guidelines of concerned countries. All appropriate information required by the regulatory authority in terms of quality of the product, safety, efficacy, analytical data, validation protocol, etc. is addressed effectively.

Once the data submitted is accepted by the relevant regulatory authority, the product registration takes place in a timely manner. In the event of a query being raised by the authority, a scientific, robust response is presented and the process of obtaining the product registration is expedited.

Dossier Preparation for Export and Registration

 The CliniExperts team can advise and develop all relevant dossiers that meet specific ACTD, EU CTD, eCTD requirements pertaining to all the scientific disciplines required for successful registration of products in Asian countries, the European Union, and all other countries (Non-CTD,Country specific guidelines).

Our Team is highly experienced in reviewing the existing dossiers and writing the required dossiers as per the client’s requirements. We provide following services to our clients.

• Writing & Review of

  • Summaries – Quality, Clinical & Non-clinical, MOA (Method of Analysis), Process and Analytical Validation, Stability Studies, Module 1 to 5, Stability studies, Certificate of analysis etc.
  • Drug Master File