Knowledge and Expertise to enable Product Access Through Optimal Discovery, Development and Approval Processes..
Biopharmaceuticals include regulated products such as recombinant products, vaccines, blood products, microbial, animal and animal tissue derived products to name a few. In India, importing, manufacturing, distribution, storage, sale and testing of these products are regulated by the Biologicals division of CDSCO (the Indian Drug Regulating agency).
Vyomus Consulting provides end-to-end Product Registration Services as well as Authorized Agent Services to all importers and manufactures of biopharmaceuticals. This end-to-end service offering will help you import, manufacture, test, conduct clinical trials and distribute your products in India (Market Authorisation), efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
This service offering includes Product Testing, Vendor Identification & Management, various stakeholder regulatory submissions, approvals management, independent audit, regulatory reporting, regulatory dossier review and submission to the regulator.
Vyomus Consulting understands product specific challenges and provides science based strategic consulting on biopharmaceuticals product lifecycle development, right from discovery, testing, validation, market authorisation to maintaining post-approval requirements. Vyomus Consulting has the competency to provide limited and specific assistance to specific regulatory, product development issues including preclinical or clinical challenges, or comprehensive oversight/management of your complete product development project in India. As we are uniquely familiar with regulatory expectations and requirements for all types of biologic, drug and medical device products, we are able to design and implement optimised, cost-efficient product development pathways which lead to product approval.
Our in-house biotech expertise can help you reach your goal quickly and in the most cost effective manner if you are geared up and ready to exploit the fact that an innovator product is soon to come off patent or even if you are already well on your way to gaining approval for your medicine or seeking to increase your product’s potential.
Vyomus Consulting can help you strategies the most optimal route towards product approval, avoid pitfalls and work within your budget, leaving you free to concentrate on what you do best. As your partner, from project conception to market approval and beyond, we work towards giving you the best commercial advantage at any stage of product development.
At Vyomus Consulting, we have content experts specialized in specific functional areas who understand the science, product development requirement, process, facility along with regulatory, divisional reviewer expectations for preclinical, clinical, manufacturing data generation, presentation and discussion.
Starting from creating a well-conceived and comprehensive Product Development Plan (PDP) which provides the most optimal pathway towards product approval to identifying and managing qualified nonclinical and clinical vendors suitable for any biologic project, we provide either specific or comprehensive services across the product development value chain as required.
Strategizing and implementing practical and successful regulatory strategies towards product commercialization is our forte. We start with geography specific well-conceived and comprehensive Regulatory Strategy document and implement the various preclinical, clinical, manufacturing tasks required to obtain product authorization in a specific market.
Product Development Services
Our specific services in this area include :
- Development of comprehensive or concise
- Product focused strategic roadmap document from discovery to market authorization
- Regulatory Strategies
- Preclinical Development Strategies
- Clinical Development Plans (CDP); Preclinical, Clinical protocols and Investigator Brochures
- Strategies for Alternative Indications
- Chemistry & Manufacturing Strategies
Regulatory Services :
- Authorised Representative services
- Regulatory Strategy Consulting and Liaison
- Complete Product Life Cycle management
- Compilation of India specific submission dossiers
- Submission management leading to approvals from ALL Stakeholders
- India Specific Labelling and Patient Information / Instructions for Use leaflets
- Post marketing services including Complaint handling, Adverse incident Reporting & Management and product recall support as part of Product safety reporting, Query management, PSUR Writing & Submission activities
- All statutory Marketing Authorization holder’s requirements
- Act as your India Regulatory Department by Applying and Maintaining required approvals, Prepare and review regulatory submission material for compliance to India legislation etc.,
- Strategic advice on development & Guidance on interactions with regulatory agencies
- Preparation/Review of regulatory submissions at all stages of product development
- GLP / GCP / GMP audits
Regulatory E-Submission Services :
- Prepare/review source documents for content and format
- Conversion of source documents to PDF format
- Creation of bookmarks and hyperlinks in PDF documents per FDA specifications
- QC and re-formatting of source documents to meet FDA electronic submissions specifications
- QC of source documents for accuracy of cross-references
- Publishing of IND, MF, BLA, NDA, ANDA submissions in eCTD and legacy format
- eCTD validation (includes: verification of PDF links, check for PDF optimization, removal of empty leaves, check for missing files, MD5 check sum update/verification, verification of XML backbone, check for compliance with ICH file/folder naming convention)
Biostatistical Analysis Reporting :
- Prepare Statistical Analysis Plan
- Provide biostatistical input into study design and protocol preparation
- Biostatistical analysis and interpretation of results
- Preparation of Clinical Study Reports
- Drug Safety Management
- Unique combination of science, biologic, drug and medical device industry and Regulatory experience
- Able to provide expert advice on a broad range of issues associated with India and international approval of biopharmaceutical products
- Extensive experience with biologic, drug and medical device development challenges, including preclinical pharmacology-toxicology