Sunshine Consultancy

The Overview

We offer a wide range of EU Regulatory Affairs consulting services to every pharmaceutical company across the globe and adhere to all the regulations on a National and International basis. Our company has earned a reputation for delivering high-quality, fast, and efficient services including license maintenance.

We have a complete understanding of the regulatory requirements as well as commercial awareness. We also design the ultimate regulatory strategy for maintenance and registration of your upcoming drug, borderline product, medical device, line extension, generic medicine, or additional indication. Whatever our clients in the pharmaceutical industry need from us concerning needs of regulatory affairs, we offer a personalised solution. From ad hoc support for your urgent project to developing a strategy design for a long-term programme and delivering unbelievable regulatory excellence through our outsource team who has expertise in the field.

Our team of professionals offer high-end services that meet consumer demands of regulatory affairs. Besides, we provide advice and supports not only at the initial stages of product development but also at the post-market assistance.

Development Stage Regulatory Affairs Support.

It takes a lot of time, effort, dedication, and money to launch a product. Years can roll by in conducting thorough research, ensuring success in every lab test, and adhering to every rules and regulation to get it through to clinical development and finally to the patients. Our goals are similar to that of our clients. We excel at building regulatory considerations and also offer amazing product development programmes.

Helping our clients is our primary goal. We do that by offering them with

Plans of Product development and gap analysis.
Investigator's Brochure writing/ IMDP/ IND.
Technical expertise regarding CMC regulations.
Orphan applications, PRIME, PIPs.
National and EMA scientific advice.

Clinical Trial Application

We have extended our expertise in developing strategies for the proposal of Clinical Trial Application or CTA. This consultancy service is offered on a comprehensive range and types of products. Our services comprise of the following:

Submissions of Competent authority.
Coordinating and authorisation of documents.
GMO applications.
CTA project management.
Submissions of Ethics.
US agent.

License and Publishing

We are proud to announce our broad choice of licensing and publishing services. You can even avail our allied services at different phases of development in addition to post-market setting of the product.

Sunshine Consultancy offers help in the situations listed in the following:

Assistance regarding every EU submission procedure.
Dossier reviews along with gap analysis.
eCTD compilation which will include EU Maas, US FDA INDs, NDAs, BLAs, and the submission of post-approval documents.
Making of non-clinical as well as clinical summaries and overviews.
Preparation of overall summaries.
PIL user testing.
TPD notifications and E-liquids.
Development of eCTD baselines and Conversion of NTA dossiers into CTD.

Post-Market Regulatory Affairs Support

Our teams of regulatory experts can handle every life cycle regulatory affair. This includes every product type from compact oral dosage formulae to sterile parenteral, locally applied, hormonal, and locally acting products that include creams, ointments and eye drops.

Sunshine Consultancy offers the following range of services:

Complete management of the National, Mutual Recognition Centralized, and Decentralized procedures. This involves the preparation of an initial MA application that will go through a complete post-approval variation and support.
The case study on the required presentation.
Regulatory strategy.
Outsourced Regulatory Affairs Department.
Training.
Overflow Regulatory Affairs Department.

DOCUMENT PREPARATION

The second a new type of drug is revealed, work starts to begin, and it doesn't end even after the product has reached the shelves of the pharmacy. The severe testing requirements are crucial and need to be encountered.

Before the submission of documents, it is essential to conduct the correct tests at the right time. The Regulatory Affairs has to ensure all of that along with the proper interpretation of the results.

The work doesn't come to an end after receiving the licence to trade a drug, it only begins. It is vital to ensure proper packaging for the medicines. It provides the necessary information to the patients that comprises both the shortcomings and benefits of the treatment.

You can leave that worry to us. We will ensure that the medicines or new treatments receive proper packaging as well as labelling. This will tell the consumers about the effectiveness of the new treatments and eliminate every risk before it reaches the markets.

The advantages of proper packaging happen to be many. One of them is preventing the misuse of it and safeguarding the consumers against its unwanted side effects. A drug is not ready to be in the market unless it has accurate labelling.

We will help you with your electronic submissions

Several Regulatory Authorities today accept only electronic submissions with eCTDs, and that applies to both the existing as well as the new submission types. Non - eCTDs and electronic paper submissions are an exception, today. However, Sunshine Consultancy is going to help you create your eCTDs dossiers. It will provide you with the following:

We will offer you with Regulatory Support during the development of pharmacies. This includes the preparation of CTD- ready documentation (CMC, Clinical, Non-Clinical, Labelling).
From developing to preparation, to assembling, and the submission of complete CTDs/ Maas for both USA and Europe registration.
We will also take care of the responses that have to be sent out to the Regulatory Authorities through assessment reports and comment letters.

REGULATORY DUE DILIGENCE

To grab the opportunities for potential licensing, the Regulatory Due Diligence has to be undertaken. We will take care of your old dossiers by filling out the incomplete data and also manage the additional studies to end your dossiers

We also prepare the required documents for our clients when they are in need of it:

The briefing documents as are necessary for EMA scientific meetings or pre-NADA.
We offer expert reports that can be for CTD pharmaceuticals, clinical overviews, or preclinical.
Mutual Recognition response documents.