We offer Regulatory Solutions to:

Cell and Gene Therapy (CGT) Products:

Gene therapy is an experimental treatment that involves introducing genetic material into a person’s cells to fight or prevent disease. Researchers are studying gene therapy for a number of diseases, such as severe combined immuno-deficiencies,  hemophilia, Parkinson’s disease, cancer and even HIV, through a number of different approaches. A gene can be delivered to a cell using a carrier known as a “vector .” The most common types of vectors used in gene therapy are viruses. The viruses used in gene therapy are altered to make them safe, although some risks still exist with gene therapy. The technology is still in its infancy, but it has been used with some success. 

With enthusiasm continuing to grow around these novel therapies, it is authoritative to understand and assess the Chemistry, Manufacturing and Controls (CMC) factors required for the manufacturing and development of commercially viable products. We have extensive experience in authoring the CMC for CGT products that will help our clients to submit the content right first time.

Key Regulatory Challenges

• Regulatory classification and strategy, differences in EU and US regulatory classifications
• IND Applications, amendments
• Product characterization (identity, viability, purity, potency, viral safety)
• Release testing (due to short shelf life and limited sample availability)
• Sterility assessment (with results often not available prior to infusion to the patient)
• Process and analytical development/validation, comparability and process reproducibility, cGMP alignment

Biological Products

Biologicals are the medicinal, therapeutic/ diagnostic/ preventive preparations that are prepared from living organisms and their products for human use. They include serums, vaccines, antigens, antitoxins, etc. Biotechnology is used as a unique approach in manufacturing such medicinal agents. We provide a regulatory strategy approach and CMC authoring services to our clients in the detailed filing of the dossier as required and do rigorous and diligent verification to successfully file the application in one go.

Key Regulatory Challenges

• Regulatory classification and strategy
• IND applications, amendments
• Interpretation of complex guidelines
• Product characterization (identity, viability, purity, potency, viral safety)
• Release testing (due to short shelf life and limited sample availability)
• Sterility assessment (with results often not available prior to infusion to the patient)
• Process and analytical development/validation, comparability and process reproducibility, cGMP alignment

Small Molecules (New Chemical Entities and Generics)

A new chemical entity (NCE) is a drug that contains active moiety that has not been approved by a Health authority in any other application. A generic drug is a copy of a brand-name drug that is developed and made by a company other than the company that makes the brand-name drug. We provide a regulatory strategy and CMC authoring services and perform rigorous and diligent verification to successfully file the application in one go.

Active Pharmaceutical Ingredients (API)/Drug Substances (DS)

Active ingredients, also known as drug substances, are the substances in drugs that are responsible for the beneficial health effects experienced by consumers. We provide regulatory and CMC authoring services to our clients in the submission of DMFs to health authorities and certificate of suitability dossiers to EDQM.

QMS Support for medical device manufacturers as per ISO 13485

The presence and implementation of a quality management system for medical device manufacturers is the key to gain confidence from regulatory authorities and customers about the product quality. Effective QMS proves management commitment towards the continual improvement of the product Quality.

We have a team of QMS experts who are IRCA certified Lead Auditors for ISO 13485.

We provide the following services.

• QMS set up from start.
• Internal audit support to assess the effectiveness of existing QMS.
• Gap analysis of existing QMS with ISO 13485 standard
• Training to the staff on QMS

Regulatory Intelligence

Regulatory intelligence is the monitoring, gathering, and analysis of publicly available regulatory information. It helps to develop a strategy for time-efficient and cost-effective drug development and drug approval. With extensive experience in regulatory affairs, we have created our own regulatory intelligence tool that can help to create a robust regulatory strategy.

We help to create regulatory reports, regulatory pathways (country-specific/product-specific) to achieve our clients to meet their targets.

Reference Standards

We help our clients to procure reference standards from various pharmacopeial bodies and deliver them for analysis purposes. We also help clients to purchase columns or other analytical materials.

Regulatory Compliance

Regulatory compliance is a driving force within the pharmaceutical industry, and it is ever-evolving to ensure safety and effectiveness. GMP is mandatory for any manufacturing facility to ensure that all the processes are being performed under a GMP environment.

Our team has extensive knowledge of GMP regulations and their interpretations, which help clients to meet various compliance requirements.

Regulatory Onsite Support

Confidentiality is a major concern while working for innovator products or technology. We have a team of experts who can support confidential projects. We provide suitable resources for on-site support to help our clients overcome the resource gap. Our resources are authorized to work in the USA, Canada, India and Thailand.