Regulatory Affairs


Regulatory Affairs (CMC) for Drugs

Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs (RA) plays an important role in the development, registration, manufacturing and ongoing marketing of pharmaceutical and biopharmaceutical products. RA professionals help ensure that pharmaceutical products which are to be registered and/or are already in market, are consistently safe, effective and are of high quality for consumers. Due to its strategic nature and its purpose to efficiently achieve regulatory approvals, RA (CMC) collaborates closely with multiple scientific, technical, quality and commercial areas within a company and/or with external contract manufacturing organizations.

RA (CMC) personnel in Athreva understand the importance and significance of regulatory knowledge, guidance, industry practices and trends; and have the expertise and experience to interpret and utilize the same for global pharmaceutical companies. With our experience in pharmaceutical industry, our goal is to provide knowledge, guidance and advice to help most effectively and efficiently achieve highest probability of success in obtaining regulatory approval of any pharmaceutical product.

Countries Supported:

Athreva can support Pharmaceutical, Biopharmaceutical and OTC companies from across the globe for their regulatory affairs requirements for major global countries. Some of the countries for which Athreva has robust expertise are - USA, UK, European Union (EU), India, Canada, Australia, S. Korea, Malaysia, Singapore, Brazil, Argentina, Mexico, UAE, Saudi Arabia

Regulatory Affairs Services

RA (CMC) Services:

1. Regulatory Dossier Creation and Review

It is not only important, but also imperative for any pharmaceutical and/or biopharmaceutical company to ensure that their regulatory dossier is complete and proper to ensure smooth regulatory registration. Incomplete and/or inconsistent dossier affects a company’s product filing process which impacts their marketing and revenue in the long term.

Athreva’s experienced RA team can assist in developing a robust and compliant regulatory dossier for globally located Pharmaceutical and Biopharmaceutical companies, including providing information for documentation requirement for country-based regulations.

Regulatory Dossier Creation and Review

2. Regulatory Strategy and Consulting

To ensure successful regulatory approval of a product, Athreva understands that an adaptive and flexible regulatory strategy is required that continuously outlines on a progressive note the regulatory requirements from the initial clinical trial phase, throughout the pre-registration, registration, post-approval and life cycle management. It is important for any company to strategize and decide on the most suitable and required registration pathway for their products in any country.

Regulatory Strategy and Consulting

3. Market Authorizations and Regulatory Filings

Market authorization and regulatory filing for products like New Chemical Entity (NCE), New Biological Entity (NBE)/Biological, Generics, Biosimilars, Vaccines and Over-The-Counter (OTC) is stringently regulated by majority of the countries across the world. Country-based Health Authorities have the responsibility to ensure that drug registrations in their countries are compliant with all the necessary regulations for marketing of safer drug products.

Athreva understands the importance of filing and maintenance of regulatory submissions for Active Pharmaceutical Ingredient (API)/excipients to various health authorities.

Athreva team along with its global partners have the required infrastructure, expertise and experience for regulatory filing of pharmaceutical and biopharmaceutical products as per country-based health authority mandated regulations. It is essential for companies to ensure that their submitted dossiers are error-free and complete so as to receive market authorization on timely note.

Market Authorizations and Regulatory Filings

4. Post Approval Changes and Life Cycle Management (LCM)

It is important for any company to ensure their marketed product continues to be compliant with the regulations of any country. In pursuit of ensuring safe products for consumers, it is essential for manufacturers and marketers to periodically update the product dossiers and also renew licenses on time with health authorities.

Athreva team has the experience to see to it that companies can ensure their existing marketed products remain compliant with country-based regulations and changing mandates.

Post Approval Changes and Life Cycle Management (LCM)

5. Local Agent Representation

It is mandatory in most countries across the world to ensure companies appoint a local representative/agent or legal representative when the latter’s product is registered in the market. The purpose of a local agent is to be the face of a company’s product in a country and be their representative in communicating with the health authority.

Athreva understands the importance of a local representative play in any country pertaining to registration and lifecycle of a product and that timely notification and/or communication to health authority is crucial in nature. Athreva has strategic partnership with experienced regulatory personnel across the globe to ensure companies receive a holistic solution from us when they enter new markets as part of their business expansion plans.

Local Agent Representation for Products

Athreva Services gives you an Edge with:

  • Multi-lingual ability to help respond to regulatory agency questions.
  • Experienced program and project managers to seamlessly coordinate with multiple stakeholders from various entities.
  • Virtual regulatory team for companies, allowing the latter to avoid expense of full-time staff and/or support them with additional workload.
  • Efficiency and cost advantage in day-to-day regulatory operational activities.
  • Standardization in regulatory strategy and activities across multiple countries under single roof.
  • Wide network of Regulatory Affairs professionals and specialists from across the globe are available to provide product specific consulting and support for local country-based requirements.