REGULATORY AFFAIRS
Our expertise supports medicines and medical devices in the areas of Regulatory affairs, Overseas Product Registration, Technical dossier preparation, Online applications with CDSCO,
DOSSIER COMPILATION
Dossier compilation is a critical aspect of the pharmaceutical and medical device industry, involving complex processes that involve meticulous documentation, stringent quality control,
REGULATORY INTELLIGENCE
Regulatory intelligence, often abbreviated as "Reg Intel," is the systematic gathering, analysis, and interpretation of regulatory information related to a specific market or jurisdiction encompassing a wide range of activities,
INDUSTRY SUPPORT
The pharma and medical device industry encompasses a wide range of documentation, including Standard Operating Procedures (SOPs), Protocols, Reports of process and analytical validations,
QUALITY TRAININGS
The medical device and pharmaceutical industry is at the forefront of innovation and is constantly evolving to meet the growing demands of healthcare. To excel in this dynamic field, professionals need specialized knowledge...
REGULATORY LABELING
Regulatory artworks for pharmaceuticals and medical devices are critical components of the regulatory submission process. These artworks include various visual and graphical elements that are used...
STATE AND CDSCO APPROVALS
Obtaining State and Central Drugs Standard Control Organization (CDSCO) approvals is a complex and time consuming process. Ensuring that your products meet regulatory requirements and are granted the necessary...
 
KNRA-50 A, Behind SBI NAC Branch, Rotary Junction,
Poojappura, Thiruvananthapuram
Kerala, India-695 012
Call Us 790-792-8343
Regulatory Affairs

Our expertise supports medicines and medical devices in the areas of Regulatory affairs, Overseas Product Registration, Technical dossier preparation, Online applications with CDSCO, preparation for regulatory inspections, compiling CTD dossiers, responding to Queries and Gap analysis.
Pharmaceutical and medical device companies operate in an industry where stringent regulations are the norm. Recent developments such as the increasing emphasis on real-world evidence and the adoption of digital health technologies, have added complexity to the regulatory landscape. To bring their innovative products to market, the companies must adhere to a maze of complex regulatory requirements. This is where pharmaceutical & medical device regulatory affairs come into play, ensuring compliance and smooth passage of products in the regulatory pathway.
At 6M, our team of highly experienced and passionate professionals works diligently to ensure that your data is transformed and structured into regulatory submissions and product approvals.

Dossier Compilation

Dossier compilation is a critical aspect of the pharmaceutical and medical device industry, involving complex processes that involve meticulous documentation, stringent quality control, and unwavering commitment to compliance, serving as a cornerstone for product registration, approval, and ongoing compliance. Dossier compilation stands at the core of this endeavor, serving as a comprehensive document that encapsulates all necessary information about a drug or medical device.In
pharmaceuticals, the Common Technical Document (CTD) format has become the gold standard, organizing information into modules that cover quality, safety, and efficacy aspects. For medical devices, the Technical File or Design Dossier provides a similar function, detailing design, manufacturing, and clinical evaluation. Thus,a well-structured dossier is essential for demonstrating the safety, efficacy, and quality of pharmaceuticals and medical devices to regulatory authorities.
Our experts possess in-depth understanding of the regional and global regulatory requirementsin interpreting guidelines of FDA, EMA, WHO, EuMDR 2017/745, MDR (India), Drugs & Cosmetics Rules,1945 and those of RoW.
At 6M, we adopt the Best Practices for Dossier - Compilation, infusing Document Control and Versioning, Cross-functional collaboration, Data integrity and Traceability

Regulatory Intelligence

Regulatory intelligence, often abbreviated as "Reg Intel," is the systematic gathering, analysis, and interpretation of regulatory information related to a specific market or jurisdiction encompassing a wide range of activities, including monitoring changes in laws and regulations, tracking competitor movements, and understanding the latest trends and best practices in regulatory affairs.
6M can guide you in data collection, analysis and strategic planning thereby accelerating product development, gaining competitive advantage and minimizing risks, thereby avoiding costly compliance issues, delays, and reputational damage.

Industry Support

The pharma and medical device industry encompasses a wide range of documentations, including Standard Operating Procedures (SOPs), Protocols, Reports of process and analytical validations, Stability, Equipment qualifications and numerous other records.
6M can well support the pharma and medical device industries with, SOP development for individual process and unit operations ,Formulation Development, Stabilization, Selection and sourcing of reference or comparator products for Bio-equivalence studies, Production Scale-up, Developing suitable process validation protocols and methods, Preparing for regulatory inspections, Vendor development,Framing User Requirement specifications(URS) and Qualification (DQ,IQ,OQ and PQ) documents for various pharmaceutical/medical devices production and analytical equipment’s, QMS (Quality Management System) documents for Medical Devices and more.

Quality Trainings

The medical device and pharmaceutical industry is at the forefront of innovation and is constantly evolving to meet the growing demands of healthcare. To excel in this dynamic field, professionals need specialized knowledge and skills and is the key to stay competitive and advanced in career in this highly regulated and rapidly changing sector.GMP training is also an essential requirement for pharmaceutical
manufacturers as per 21 CFR 211.25(a)- Personnel Qualifications and is mandatory for both drug manufacturers and ingredient suppliers. Stay competitive, stay informed, and stay ahead with the customized training modules by 6M professionals.

Regulatory Labeling

Regulatory artworks for pharmaceuticals and medical devices are critical components of the regulatory submission process. These artworks include various visual and graphical elements that are used to convey important information about the product to regulatory authorities, healthcare professionals, and consumers. The process typically involves collaboration between regulatory affairs, quality assurance, packaging design, and production teams to create and maintain accurate and compliant regulatory artworks. Various levels of regulatory artworks include design and layout of Inner and Outer cartons, Instructions For Use (IFU) and User Manuals.Medical devices often use symbols and pictograms to convey information quickly and universally, which must adhere to specific standards, such as ISO 15223- 1, to ensure consistency and clarity.Certain products, especially pharmaceuticals, may use color coding or include Braille text on labels to enhance accessibility for individuals with visual impairments.
Here at 6M, we can help you to figure out the optimum artwork solutions to outfit the regulatory requirements of India and overseas nations as per the respective regulatory requirements.

State and CDSCO approvals

Obtaining State and Central Drugs Standard Control Organization (CDSCO) approvals is a complex and time consuming process. Ensuring that your products meet regulatory requirements and are granted the necessary licenses in a timely manner is crucial for market entry and compliance.
Sixth Module has special expertise in filing offline and online applications with the State & CDSCO Medical Device and Sugam Portals, helping the clients to significantly reduce the time for approvals.