Our services
Competitive Intelligence
Competitive intelligence in the pharmaceutical industry is critical to understanding the landscape and one’s place within it. Without accurate and timely market intelligence, pharma companies risk the success of their drug development and marketing plans and may overlook important market gap opportunities.
Create a regulatory strategy
Creating a regulatory strategy is an essential part of the early development of a pharmaceutical drug. Its purpose is to align regulatory requirements with the business or marketing objectives of a product.
New Product Authorization
To make a marketing authorization application (MAA), our regulatory team support in submitting a comprehensive dossier to the appropriate competent authority(s) (CAs) for assessment and approval.
Life Cycle Management of products
Pharmaceutical product lifecycle management is about maximizing the value of products to their customers. This includes new indications, improved formulation, new delivery system or packaging, IT solutions, etc., to expand the utility, and improve upon efficacy, safety and the patient experience. The team here efficiently support for product lifecycle management.
CMC Advisory
Our Team support and facilitate the process from idea to a new drug product on market within CMC development. Bridging between development and production of new biopharmaceutical products. Counsel biopharmaceutical developers and Bio-investors within e.g. due diligence and CDMO/CRO selection.
API/DMF
We provide expert consulting and efficient services for quality Drug Substance submissions for US, EU, and other countries. This includes Certificate of Suitability (CEP/COS) submission to the European Directorate for the Quality of Medicines & Healthcare (EDQM). Our Team assists customers for the processes and documentation involved in filing and reviewing the Drug Master File (DMF) or Active Substance Master File (ASMF).
Dossier
Regulatory Experts Solutions provide registration file for drug product registration in various countries all over the world for many Pharmaceutical Company in INDIA & for our International Business Associates. We Provides Registration Dossier service in Dossier Compilation, Dossier Preparation & Dossier Review in accordance to the respective Regulatory Authority Guidelines.
Pre-screening of Documents for submission
Our Team provides support in pre screeening of documents suitable for submission to competent authority.
Timeline Managements
Our Team responsible for putting together and managing the timeline for the drug trials approvals and ensuring their complete follow up with the competent Authority
Gap Analysis and Remediation
Our Team expertise in gap analysis that help lead an organization to not only improve their processes, but recognize which processes are in need of improvement
On-line demand
We have On-line demand consultants. Industry experts, whenever you need them. Our fully-managed Statement Of Work (SOW) and contractor solutions ensure you reach the desired technical outcome in a way that works for you.
Regulatory Compliances for local licenses at Legal Metrology & States
Our Team have experts from different domain. It helps to the customers to follow Regulatory Compliances for local licenses at Legal Metrology & States