Regulatory Services

KNOWLEDGE, EXPERTISE, METHODOLOGY, & RESOURCES AT EACH PHASE OF PLANNING & IMPLEMENTATION TO ACHIEVE FASTER PRODUCT AND PRODUCT DEVELOPMENT APPROVALS.....

Optimus Pharma Consulting specializes in providing customers with expert solutions for the development of Therapeutics and Medical Technology (MedTech) based Products in India. We provide Regulatory, Product Development expertise and resources through all stages of product development to enhance submission preparation and achieve faster product and product development approvals leading to enhanced access to Markets and Opportunities.

Developing and Implementing an optimal regulatory strategy is critical for efficient product development and successful approval of products. Optimus has significant experience in helping customers understand regulatory requirements along with developing and implementing regulatory strategies leading to first-cycle approvals in India.

BETTER THE ROADMAP FASTER ONE GETS THERE !

Whether your company is global or a start-up, we provide the help you need for faster access to local Markets and Opportunities. We help you succeed throughout the product Lifecycle :

We have expertise with all products and development activities regulated by various regulators. Our overall experience includes over four hundred preclinical, clinical trial approvals, product registrations, marketing authorizations, import and marketing authorizations, manufacturing and marketing authorization and transactions covering a large number of therapeutic and product categories.

Integrating Science, Regulations, Measurable Business outcomes and combining local knowledge with global standards, our team moves beyond providing expert advise to get your project off the ground, move at a fast pace and achieve faster product and product development approvals. We develop and manage a distinctive and compelling regulatory strategy to facilitate execution of smart and effective regulatory projects by working hand in hand with customers involved in drug discovery, development and commercialization. Optimus offers the following services in this area.....

REGULATORY INTELLIGENCE REGULATORY STRATEGY REGULATORY SUBMISSIONS PROJECT MANAGEMENT ON-DEMAND CONSULTING
Product specific requirements Scientific & Regulatory assessment Preclinical & Clinical Development Plans Project Management Plan Regulatory insight & Clarifications
Precedents & current thinking Product Development Plan Protocols, Investigator brochures Outsourcing-identify, manage, optimize Strategies & Solutions
Product specific RI Status Document Regulatory Strategy & Roadmaps CTA, IND, BLA, NDA, MAA, CTD, DMF Analyze & optimize performance Product Development Process optimization
Risk Plans Approval Maintenance Education & training
Compliance Audit services
We at Optimus have a thorough understanding of regulations governing industries that manufacture and market medicine (Rx/OTC), biologics, medical devices, blood products, cosmetics, animal drugs, dietary supplements, food, and colors.

PRODUCTS :

All Products and Product Development Activities regulated by various Indian Regulators (Eg : Biologicals, Biosimilars, Vaccines, Pharmaceuticals, Advanced Therapeutics, Generics & OTC, Veterinary Products, Medical Devices, Nutraceuticals, Cosmetics, Diagnostics, Insecticides & Pesticides etc.,)

Our experienced senior regulatory professionals offer expert consulting and approach regulatory issues and processes in an innovative way and guide your organization throughout the life cycle of your regulated product.

We anticipate pitfalls before they occur, outline a clear pathway for advancement, and maximize your investment and program success. Our regulatory group specialises in rescuing regulatory projects which need specific consultation in restructuring, restrategising and or reimplementing.

Our expert services can begin early in development with preparation for filing the initial regulatory submission (such as review of existing data and filing an IND/CTA/NDA/CTD/eCTD) and can continue through product launch. Post-marketing regulatory services include post-approval periodic reporting as well as managing developmental programs for new or extended indications, new dosage forms, variations, renewals.

The Regulatory Services team at Optimus is flexible to fit your needs. We can provide selected or comprehensive services either from our facility or onsite at your facility as required to meet your specific program needs.

Contact us to know more.....